Pfizer

Myocardial Infarction: patient began to complain of severe chest pain 3 hours after the vaccine was given .. Vaccine NDC # 59267-1000-1. 0.3 ml given by RN. Patient called his PCP: "... I had very bad chest and shoulder pains, neck pains and slight fever from 9 pm until early this morning (Jan 8). My blood pressure was 155/95 mmHg. Should I see you today? Still feel sore all upper body. Above message received at 0720 am (Jan 8) and the patient was called back at 0757 am (Jan 8): patient was told that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the patient go to the emergency room. Patient understood the importance to seek medical attention..... Emergency Room notes: seen by MD on Jan 9. Note at 0749: patient complained of chest pain on/off since received COVID vaccine on Jan 7. Pain was substernal and radiated to the left shoulder, assoc with some SOB. EKG obtained and revealed ST segment elevation and a "cardiac alert" was called.

Some time after vaccination noticed trouble breathing and shortness of breath. 2 days later ( Tuesday, 1-18-2021) still have difficulty breathing and heart beat is faster. Woke up in the middle of the night on Sunday with a rapid heartbeat.

Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64. He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.

Abdominal rash with hives, right arm rash with hives, eye itching, nasal itching, throat swelling sensation

4.5 days after vaccination he woke from a sound sleep with extremely fast heart, unable to breath, Apple Watch said "Afib". went to ER and cardioverted on his own and was discharged after 5 hours. MD later increased his HCTZ.

Upset stomach, headache, severe entire body aches short of breath, diarrhea, chest pressure, chills, fever and body weakness. Talk to Dr. and she recommended to drink plenty of fluids, take Tylenol , and rest.

12-14 HOURS AFTER RECEIVING THE VACCINE PATIENT REPORTS HE DEVELOPED HEADACHE, MUSCLE ACHES, CHILLS, SWEATS, LOSS OF APPETITE. HE ALSO NOTED A RASH ON HIS NECK, FIRST ON THE NECK AND NOW HAS SPREAD TO THE ENTIRE BODY. PATIENT ALSO REPORTS SHORTNESS OF BREATH WHEN LAYING FLAT ON HIS BACK THAT STARTED AT THE SAME TIME.

Fever, Lightheadedness, Shortness of breath 15 minutes post vaccination felt very dizzy with SOB. Had similar symptoms 2 days ago. Found to have temp 101.5 Sent via butler to ED for further evaluation

Runny nose, sensation of throat closing up, difficulty swallowing. I could continue breathing nasally and could also drink water. Event cleared up around 6:00 PM the same day (date of vaccination).

Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/24/2021 Patient: DOB: Date: 3/24/2021 MRN: Subjective Patient is a 60 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection he did fine. However, pt noted to be sitting on side after pushing his sister in wheelchair to take a "break." He was noted to be wheezy and sob along with diaphoresis. Pt states he has hx of asthma and forgot to bring his inhalers. He normally doesn't walk much anyway and today was a long walk. He was offered a wheelchair and brought to the bay for inhaler treatment. . He denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms. Active Problem List Diagnosis ? Essential hypertension [I10] ? Long term (current) use of anticoagulants [Z79.01] ? New onset atrial fibrillation (HCC) [I48.91] ? Neuropathy (HCC) [G62.9] ? Hypotonic bladder [N31.2] ? Diverticulosis [K57.90] Per previous hx report, colonscopy 2004 ? Diabetes mellitus type 2 in obese diagnosed 2014 [E11.69, E66.9] ? Class 3 severe obesity due to excess calories with serious comorbidity and body mass index (BMI) of 45.0 to 49.9 in adult (HCC) [E66.01, Z68.42] ? Unspecified hemorrhoids without mention of complication [K64.9] ? Open wound of other and unspecified parts of trunk, without mention of complication [IMO0002] ? Obstructive sleep apnea (adult) (pediatric) [G47.33] ? Hypertrophy of prostate with urinary obstruction and other lower urinary tract symptoms (LUTS) [N40.1] ? Degeneration of lumbar or lumbosacral intervertebral disc [M51.37] ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath and wheezing Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/24/21 0825 Pulse: 89 Resp: (!) 24 SpO2: 100% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Tachypnea present. Breath sounds: Decreased breath sounds and wheezing present. Comments: Albuterol inhaler used. Improved with use. O2 maintains at 100%. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Pt with reported improved symptoms and breathing after 2 puffs of albuterol. Pt declined blood pressure check. Heart sounds RRR. Improvement of wheezing and air movement. Eupneic. Skin dry. Assessment/Plan Treatment included: albuterol Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Asthma exacerbation due to exercise. Recommend keeping albuterol on him at all times if he is out of the home. Continue maintenance. Follow up with pcp accordingly. APRN Electronically Signed 3/24/2021 8:31 AM

12 hours later belly cramps. 24 hours later shortness of breath. Still can't take more than a few steps without getting out of breath.

Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and chills Related difficulty urinating and frequent urination due to prostate inflammation Loss of memory (Brain Fog?) in which I had no memory of events occurring from 3/7-3/9 and little memory on 3/10. Memory was close to normal on 3/12. Two Covid tests with negative results (taken on 3/8 and 3/11) Some lung congestion which could be due to bloody sinus mucus and post nasal drip I did retain my sense of smell and taste but had no appetite and did not eat or ate very minimally from 3/7pm until 3/11pm Very fatigued and weak with knee, hip and general joint pain. Increasing levels of fatigue started on 3/2 with little energy from 3/7-3/11. Fatigue is mostly gone as of 3/23.

Needed to be hospitalized the day after vaccine dose due to a hypertensive emergency; fluid build up in my lungs; I could not breathe had to call an ambulance; another vaccine of Pfizer with the first dose on 14Mar2021 on arm; This is a spontaneous report from a contactable consumer (patient). This 60-years-old male consumer received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration administered in arm left on 14Mar2021 11:00 at single dose for covid-19 immunisation . Medical history included diabetes, kidney disease, hypertension, no known allergies. There was no COVID prior vaccination. Concomitant medication included another vaccine of Pfizer with the first dose on 14Mar2021 on arm. No other vaccine in four weeks. The patient need to be hospitalized the day after vaccine dose due to a hypertensive emergency and fluid build up in his lungs. He could not breathe had to call an ambulance. The event onset was on 15Mar2021 at 03:00 PM. This has never happened to him before and he was otherwise very healthy. The patient had to go into intensive care still in hospital after 4 days. The events resulted in emergency room/department or urgent care, hospitalization for 5 days, life threatening illness (immediate risk of death from the event). The outcome of the events hypertensive emergency and fluid build up in his lungs and could not breathe was not recovered. COVID tested post vaccination included nasal swab on 16Mar2021 with result negative. No Follow-up attempts are possible. Information on Lot/Batch number can not be obtained.

Patient reported for second dose in series. Disclosed that his throat swelled up that day. He took diphenhydramine and it resolved. Recommended patient hold off on completing the series until speaking with their primary care physician.

Saturday 313 am, chills, 400am extreme sweats ended by 630am - 718am unable to breathe, It felt like right lung collapsed. I was able to pull up breath, however light chest pain persists at this time, 12;12pm.

Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, extreme fatigue, Abdominal cramping. Day 2-Injection site pain, Nausea, fatigue.Day 3-Nausea,fatigue.Day4-Extreme lower and mid back pain, indigestion, gas, bloating, constipation.Day5-Fatigue lower back pain.Day6-Fatigue,lower back pain.Day7-Fatigue,lower back pain.Day8-Fatigue, Rash appears on torso and back, red bumps and itchy, Fever onset.Day9 Fatigue, Fever, rash itchy red bumps.Day10-Joint pain onset, Knees swollen large, reduced range of motion, hamstrings cramped up. Feet swollen and tingling. Rash over entire torso.Day11-rash abated, knees and legs swollen with limited range.Day12-Cramps hamstrings and knees swollen. Day13-Knees and leg cramps, fatigueDay14-Knees and legs cramped, fatigue.Day15-nausea,fatigue, hives on side and feet.Day16 Migraine onset, severe nausea, high fever, no sleep.Day17- extreme migraine, fatigue, nausea, hives.Day18-migraine,nausea,hivesDay19-Nausea,hives,fatigueDay20patchy hives, fatigue. Fatigue through to April 1, Skipped second dose.

SOB, nausea, headache. Felt chest heaviness. Vital signs wnl, O2 sat 97%. Given albuterol 2 puffs. Went to ED.

weakness, nausea, vomiting, shortness of breath, diarrhea, muscle aches concern about antibody-dependent enhancement

12 hours later belly cramps; 24 hours currently shortness of breath; This is a spontaneous report received from a contactable consumer. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: er8732), via an unspecified route of administration, administered in Arm Right on Mar2021 12:00 PM at a SINGLE DOSE for covid-19 immunization. Patient had a history of gluten sensitivity from an unspecified date. The patient's concomitant medications were not reported. The patient experienced 12 hours later belly cramps (abdominal pain upper), shortness of breath (dyspnea) on 24Mar2021. The outcome of the events was not recovered. Information related to case additional information has been requested.

Symptoms began within 15 minutes of vaccination. C/o shortness of breath/chest tightness, "wheezing," had 1 episode of diarrhea. Sent to ED, given tylenol, zofran ODT, solumedrol, diphenhydramine injection. Diagnosed with allergic reaction and discharged to home with oral steroid.

Pt. with hx of hypoxia, oxygen at night, CAD, seizure disorder. Started feeling light headed, SOB of 4-5 min. after injection. Pt.brought to procedure room. Initial vs at 4:20, 118/78, p 105, r 18. O2 placed, sat up to 98% on 2l. 911 called. Started feeling better on o2. SOB improved. Due to hx of CAD, epi not given. PE: heart rate reg 95, lungs cta, upper airway without stridor, swallowing well. Squad arrived. Repeat bp 120/80, sat 98%, r 16. pt. exhibited some shakes and felt he might seize. Shakes stopped in 10 sec. Transported in stable condition to ED.

Pt states about ten minutes after receiving vaccine, they began to feel dizzy, labored breathing, and a tight throat. Pt transferred to Med. Obs. via wheelchair and was transferred to bed in semi-fowler position. Pt given water and crackers. Pt was instructed to rest. Pt stated they began to feel better after resting. Pt was advised to take 25-50mg of Benadryl at home as a precaution and to call 911 if the symptoms reoccurred.

Pfizer-BioNTech COVID-19 Vaccine EUA Pt presented to ED on 4/10/21 @0523 with c/o SOB, F/C and cough. Admitted to ICU with acute hypoxic respiratory failure on BiPAP, non-STEMI, acute decompensated heart failure, acute kidney injury and suspected severe sepsis. Reportedly received 2nd dose of COVID-19 vaccine 2 days prior. Shortly after admit, pt developed worsening respiratory status requiring intubation @1045. Pt with continued hypoxemia despite 100% FiO2 and PEEP of 15. Pt experienced cardiac arrest with PEA @1100 with return of spontaneous circulation. Repeat arrest with PEA@1135 with return of spontaneous circulation. Family decision to change code status to DNR CCA, repeat arrest- time of death 1203.

Temporary: aches, chills, fatigue Ongoing: chest pain/discomfort with activity, short breath, headaches, fatigue

To bed about 10:30p. Awoke 11:30p & could not talk, shivering uncontrollably, couldn't move my legs, & no feeling in feet & legs. Very difficult to breathe. Was alert. Wife up to BR, looked over, I was trying to say help. Brought me water. she assisted me up , then back to bed, still shivering uncontrollably. 30 mins to 1 hr later, my son saw me in the hall and said, "Dad, you look like ****". I could not make a sentence. Per my son all I said was, "Gatorade". I drank it then fell asleep. next morning 101 temp, severe fatigue, severe aches and pains, could not make complete sentences I was told. I did have COVID 19 for 4 weeks Oct-Nov 2020.

2 weeks after 1st dose of covid vaccine, some fatigue and sob. The next morning, sudden onset of sob, chest pain. To Emergency department, cath lab, stent. Home within 36 hrs.

Injection site soreness, tiredness on 4/27/21. At 2 a.m. on 4/28/21 woke up with chills, sweats, fever of 102, headache, muscle pain, joint pain, nausea, feeling unwell, dizziness, weakness, injection site soreness, somewhat fast heartbeat, shortness of breath. If he talked then short of breath and would cough. About 8 a.m took 1 Tylenol. About 9:30 a.m. had major stomach cramps, barely walk but made to bathroom to throw up. Used cold wash cloth for his fever then after he threw up he ate one piece of toast, took his medications and 1 Tylenol (since he threw up the first one). Heart rate better and breathing better. Went back to bed to go to sleep about 10:30 a.m.

Client (DOB:08/14/1960) received the 2nd dose of Pfizer COVID vaccine lot # EW0179 and expiration date 5/1/21 at 12:36pm. Client received first dose of Pfizer on 3/31/21 and had no reaction. Vaccinator noticed client had some trouble with balance as he was walking in so right after vaccine vaccinator was there as support to help client walk to observation area and then he seemed more off balance so she got him a chair. Vaccinator alerted RN who walked over to observation area to get EMT. PHN overheard client saying his "throat is closing up" and alerted PHN about emergency and then ran to get Ekit. PHN got ekit from observation area and returned to client and other RN stayed to assist in observation area. PHN called 911 at 12:40PM. Client reports having a diagnosis of lymphoma 4 months ago and being treated for fungal pneumonia 3 months ago to PHN who started to take notes. Client was in a chair when PHN arrived and opened ekit to give epinephrine, which client declined. First set of vitals taken at 12:42pm: blood pressure:130/50 , pulse:83, and oxygen:96%. At 12:44PM FIRE Department arrived and assumed care. Client was transported by paramedics out of the building at 12:53PM.

On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home and I was finished with work at 7pm. My legs felt like led weights and my right hand had lots of joint pain. I ate supper at 7pm. It was getting towards 8pm and was starting to have signs that Unintentional tremors. shaking in my legs, hands and head. I laid in bed and it was far worse, this was a seizure. was having hard time speaking or breathing at times. I managed to take a clonazepan and with in a hour it starting to calm down.

Initially no reaction. Vaccinated in the morning, played golf in the afternoon. Early evening began experiencing shortness of breath, which became severe in a short period of time. Called 911. Paramedics arrived and administered care and transported me from my home to the Medical Center emergency room.

Fever; felt like trash and didn't feel good at all; both of his pinkies down to his wrist were numb; Got really winded; didn't have any oxygen; Got really winded; didn't have any oxygen; Uncontrolled Chills; he was shaking like crazy and he couldn't get warm enough; Sore Right Arm after Second Dose; he was shaking like crazy and he couldn't get warm enough; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (BNT162B2), dose 2, administered in arm right on 14Apr2021 09:50 (Batch/Lot Number: EW0158) as single dose at the age of 60-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient received bnt162b2 (BNT162B2), dose 1, administered on 18Mar2021 09:50 (Batch/Lot Number: EN6208) as single dose at the age of 60-year-old for COVID-19 immunisation and experienced on 18Mar2021 17:10 left arm hurt and on 19Mar2021 felt really fatigued, recovered on 25Mar2021 and 20Mar2021 respectively. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 22:00 the patient experienced got really winded; did not have any oxygen, uncontrolled chills, sore right arm after second dose, he was shaking like crazy and he could not get warm enough, he was shaking like crazy and he could not get warm enough. On 15Apr2021 the patient experienced 102 degree fever fever, felt like trash and did not feel good at all, both of his pinkies down to his wrist were numb. The course of events was as follows: On 14Apr2021 after his second shot that evening around 10:00 P.M., he had uncontrollable chills. He could not hold a cup of water without spilling it. He fought that off and it calmed down and he fell asleep. The next morning on 15Apr2021 he felt like trash and did not feel good at all and he had a 102 degree fever. He took Advil as treatment and one hour later he sweated that out and his fever went away then. Both of his pinkies down to his wrist were numb for the rest of the day and the next morning, his left hand was already feeling back to normal, and his right hand took the rest of the day and it got back to normal. No event required a visit to Emergency Room or physician office, but he almost went to the ER with the second dose because he was shaking like crazy and he couldn't get warm enough, but finally it wore off. It got to a point where he did not have any oxygen, he was shaking that bad. When he went up the stairs, he got really winded and sat and down. It lasted at least an hour, during that time he was awake he was trembling bad and couldn't get warm. When he quit shaking, he fell asleep. Patient stated his wife mentioned something about they gave him some tests, like COVID Experimental Drugs, when he was in hospital for 12 days. He could not even tell the names of them. That was 15-27Oct2020. He did not know if that has anything to do with his reaction. The outcome of got really winded; did not have any oxygen, he was shaking like crazy and he could not get warm enough was recovered on 14Apr2021, of uncontrolled chills, fever, was recovered on 15Apr2021, of sore right arm after second dose, both of his pinkies down to his wrist were numb, felt like trash and did not feel good at all was recovered on 16Apr2021.

Fever, chills, sweats, rigors, cough, shortness of breath, right sided chest pain, pneumonia- confirmed on cxr and Ct chest, small pleural effusion, hypoxia, decreased BP.

4 days after shot woke with headache and difficulty breathing. Deep breaths would hurt a bit and sometimes cause a cough. Temp was 99.7 to 99.9 for 2 days. Lethargic for about 4 to 5 days after start of symptoms.

About 1 week following first Pfizer vaccination, I began having achiness in left leg and thought this was possibly from sitting in a chair without enough cushion. I simply could not get leg comfortable. Over a couple days duration the leg continued to be achy and slightly swollen. On December 23rd at night I awoke due to such discomfort in leg and could not get comfortable enough to go to sleep. I went to ED where I was examined and found to be mildly short of breath and in pain. Ultrasound of leg showed large upper leg DVT. CT of chest showed submassive Pulmonary Horseshoe Embolus. I was placed on Heparin and anticoagulated. Hospitalized for several days while anticoagulated and observed for any clot progression or respiratory distress and discharged home on Xarelto for anticoagulation and follow up with PCP, Hematology, Pulmonary medicine.

Shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included lung cancer from an unknown date and unknown if ongoing. Concomitant medications included lorlatinib, alprazolam, rosuvastatin calcium (CRESTOR), lisinopril and steroid, all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (Batch/Lot number was not reported) for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021, the patient experienced shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization. The patient was hospitalized for this event for 1 days. This event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included oxygen and home oxygen, albuterol nebulizer, vento. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: negative. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 27Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing tremors and prostate issue. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included clonazepam, tamsulosin, oxybutynin. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Apr2021 (the first day), the patient was a little tired. On 28Apr2021 (the second day), the patient experienced joint pain, felt very tired and weak. By 19:00-20:00, the patient realized he was going to have a tremor attack, but quickly turned into what would be called a seizure. The patient lost motor skills, speaking and breathing issues accrued. The symptoms where coming and going. With the help of his wife, the patient managed to take one 0.5 mg clonazepam. The situation lasted for around an hour, after which the patient went to bed. The next morning, 29Apr2021, the patient still had a lot of joint and muscle pain. As soon as he tried to start some minor work around the house, the tremors started again, but this time the patient took clonazepam and rested in bed all day. Today, 30Apr2021, the patient was tired from the situation and will be resting also. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of seizure, " tremor attack / tremors started again", joint pain, tired, weak, lost motor skills, speaking and breathing issues accrued and muscle pain was resolving. Information about lot/batch number requested.

Pt complained that he "can't breathe" & dizziness. Hx of COPD & DM. BP 143/90; HR 120; RR30. Provider at bedside & given water & crackers. BP after 10 min 157/100; HR 120; RR 36. Taken by wheelchair to car, stable & released from vaccination site

Office Visit 3/12/2021 WellSpan Family Medicine - Crossroads DO Family Medicine COVID-19 virus infection +10 more Dx Fever Reason for Visit Progress Notes , DO (Physician) ? ? Family Medicine ? ? Encounter Date: 3/12/2021 ? ? Signed Expand AllCollapse All Office Visit Assessment/Plan Diagnoses and all orders for this visit: COVID-19 virus infection Suspected COVID-19 virus infection - POCT COVID-19 Antigen Mild intermittent asthma without complication Essential hypertension with goal blood pressure less than 130/80 Coronary artery disease involving native coronary artery of native heart without angina pectoris Paroxysmal atrial fibrillation (CMS/HCC);Gastroesophageal reflux disease without esophagitis;Irritable bowel syndrome with diarrhea;Hyperlipidemia with target LDL less than 70;Chronic anticoagulation;Close exposure to COVID-19 virus;covid Ag is positive;MAB tx Clinical Support 3/12/2021 WellSpan Infusion Center - Ephrata RN COVID-19 virus infection Dx Medication Infusion Reason for Visit Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/12/2021 ? ? Signed arrived to the ambulatory infusion site with his wife via car. Reports intermittent fatigue, dizziness, diarrhea, nausea, dry nonproductive cough, and shortness of breath, stated he discussed Bamlanivimab infusion and associates risks with his doctor prior to this infusion. Reports all question were answered to his statisfaction. Denies any concerns or needs at this time.

Patient experienced sensation of throat closing and SOB. The next morning, he felt as if his throat was swollen. He has never experienced this sensation or reaction to vaccines in the past.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild

Pt was admitted on 5/10/21 c/o of rigor. Patient complains of fatigue, weakness, intermittent fevers up to 100.8 °F. EMS found patient to be hypotensive up to 84/52 and tachycardic up to 120s per minute. He woke up the morning of admission and then began to have shaking rigors at 10 AM and felt profoundly fatigued, dizzy and lightheaded. Patient does have a history of COPD which is non-O2 nonsteroid dependent and has some chronic shortness of breath. He does use inhalers and nebulizers and also continues to smoke. He also has a history of melanoma who follows with provider. In the ER he was found to have hypotension and was given 2 L of IV fluids. He also had a 3 g drop in his hemoglobin over the past 5 days and there was concern for a possible upper GI bleed. Because of the hypotension and drop in hemoglobin he was admitted to the ICU. He was started on Protonix IV. Chest x-ray, CT of the chest CT of the abdomen and pelvis were unremarkable for any acute process. He was admitted for unspecified shock which was initially thought possibly due to sepsis but this was ultimately ruled out. He was treated with 5 days of vancomycin and Zosyn and then antibiotics were discontinued. Patient's troponin was elevated with an elevated delta. He was seen In consultation by cardiology who felt that no further cardiology work-up was needed the cause for the patient's hypotension was unclear but his home lisinopril was discontinued. he did require albumin but not pressor support. As he was more stable he was transferred out of the ICU to the medical floor. He was started on midodrine. His blood pressure has improved he has remained afebrile throughout his hospital course he has remained stable off antibiotics. At this time he is medically stable for discharge to home and will continue on midodrine for new autonomic failure/dysfunction. the cause for his fevers/rigors was not found

Per triage notes on 4/21/21: Pt had his 2nd COVID vaccine today at 0800. At 0900 developed lip swelling. Took two doses of Benadryl and has now developed chest tightness and throat swelling. Per doctor's notes: Patient is a very pleasant 60-year-old gentleman who comes in for evaluation after a possible allergic reaction today, possibly related to a second dose of Pfizer Covid vaccine that he got at 8 AM this morning. About an hour later he started to feel flushed. He felt like his face was warm and his ears were warm. He started to feel like the inside of his mouth had filled with a rubber ball. His tongue felt full and he started noticed progressively that he felt like he was having difficulty swallowing. States that he never actually had any lip swelling, contrary to the triage note, just felt funny in the interior of his mouth. Did feel like his tongue was slightly swollen, both based on the fact that it felt "thick" when he was talking, and on direct inspection, as well. Took 50 mg of Benadryl around the time that his symptoms started, and lay down to nap for a little while. When he woke up he was still feeling like he was having more difficulty swallowing. He also felt like his face was a little bit puffy, prickly under each eye. He also felt like he had a blotchy rash on his chest and upper back, which his wife corroborates. He felt like his chest was a little bit tight and that something was heavy on his chest, though he was not wheezing or acutely short of breath, per se. Took another 50 mg of Benadryl at about 2:15 PM, and presented to the emergency department for further evaluation. Currently still has a little bit of chest tightness and throat tightness. He feels flushed. Symptoms have not worsened, but they have not completely resolved, either. He has had anaphylaxis in the past and has had to be admitted to the hospital. And this was in relation to taking doxycycline, it sounds like. Patient presented again to the ED on 4/22/21 with the same symptoms. He was admitted with anaphylaxis. Per ED notes, also diagnosed with Angioedema, improved. Likely related to second covid vaccine. Cant rule out secondary to Lisinopril.

had a respiratory or breathing episode; did go into cardiac arrest; complaining of pain; breathing issues; This is a spontaneous report from a contactable consumer (patient's caregiver). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as 1st dose, single (patient was 60 years old at the time of vaccination) for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that on an unspecified date, Friday or Saturday, the patent was complaining about breathing issues all of a sudden, he had respiratory or breathing episodes. The reported stated that that they called 911 right away, and they came and picked the patient up. The patient had trouble breathing and was complaining of pain, and he did go into cardiac arrest, but they checked, and it was not a stroke or a heart attack, none of those things, they cannot figure it out. It was reported that nothing was wrong with the lungs, and the hospital was treating the patient by currently having him sedated and treating his pain. The outcome of the events was unknown.

Post vaccination at approximately 10:30 am client reported feeling numbness and tingling in hands, developing a cough and a subsequently developing a felling of throat "closure" or tightness. Client was evaluated by Emergency response team and relocated to the Emergency response tents. At 10:45 am client was noted to become hoarse and requiring neck extension to swallow water. Client at this point was reported to be unable to speak in full sentences. Epinephrine was administered by Emergency Response physician at 10:50 AM. EMS was on site, oxygen was administered and transport to a nearby hospital emergency room was initiated and completed. Note: In retrospect client stated that he had similar symptoms after his first intramuscular vaccine dose (Pfizer, three weeks prior) for three days and had self medicated with Benadryl but had subsequently felt better.

Patient presented to the ED with shortness of breath and was subsequently hospitalized with COVID-19 pneumonia. This was within 6 weeks of receiving COVID vaccination.

Developed shortness of breath and high blood pressure within 48 hours. Chest pain and back pain. Shortness of breath when working out slightly.

Sharp chest pain, neck pain, difficult/painful breathing, emergency room trip, diagnosis of Pericarditis

Patient presented to the ED and was subsequently hospitalized for Acute respiratory failure with hypoxia and hypercapnia within 6 weeks of receiving COVID vaccination.

Talking caused SOB & nauseous/vomiting; Talking caused SOB & nauseous/vomiting; Fatigue after vaccination; fatigue increases.; Passed out at end of trip (confirmed ventricular tachycardia); Passed out at end of trip (confirmed ventricular tachycardia); Unable to walk > 10 ft/During trip, difficultly walking uphill; By midMay tolerates walking but gets SOB on staris/talking caused SOB & nauseous/vomiting/By midMay tolerates walking but gets SOB on stairs; Admitted to hospital (6/4) in 100% A fib & significant ventricular arrhythmias.; Admitted to hospital (6/4) in 100% A fib & significant ventricular arrhythmias; Continued to worsen; Right ventricle pumping inadequately; Cardiogenic shock; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration, on 23May2021 (at the age of 60-years-old), as unknown dose, single dose for COVID-19 immunization and varicella zoster vaccine RGE (CHO) (SHINGRIX) on 27May2021 for immunization. Medical history was not reported. Concomitant medications included Furosemide (LASIX). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 after vaccination, the patient experienced fatigue and it was increased. By mid of the May the patient tolerates walking but got shortness of breath (SOB) on stairs. On 20May2021, the physician doubled Furosemide (LASIX) dose for unspecified trip. During the trip, the patient had difficulty walking uphill. It was reported that patient passed out at end of trip, it was confirmed with ventricular tachycardia. On an unknown date, the patient underwent echocardiogram, and the ejection fraction was 25%. On 04Jun2021, the patient admitted to hospital in 100% atrial fibrillation & significant ventricular arrhythmias. The patient was treated with Intravenous heparin and he was kept for 2 nights in the hospital. It continued to worsen. On 08Jun21, the patient was unable to walk more than 10 feet, while talking caused shortness of breath and nauseous/vomiting. The patient was admitted to another hospital. On an unknown date, in hospital the patient had an esophageal echo to rule out (R/o) any clots in heart or lungs. On 09Jun2021, a cardioversion and on 10Jun2021, an angiogram was performed, it did not show any blockage or valve problems but showed the right ventricle pumping inadequately. The patient was advised new medications which included amiodorone. The patient was currently diagnosed with cardiogenic shock and expected to remain in CCU (cardiac care unit) until end of week. It was also reported the patient was hospitalized for Life threatening illness (immediate risk of death from the event). Seriousness criteria was reported as life threatening and prolonged hospitalization. The outcome of all the events was unknown. Information on Lot/Batch number has been requested.

Started to have chest pains a few days after vaccine. I passed out and was unresponsive with no pulse and breathing. Received cpr from my partner who found me on the floor at approximately 2:00am on 5/16/21. I was taken to the emergency room of the hospital and underwent extensive tests of the brain: CT scan, MRI, Angiogram, and Spinal Puncture. All tests negative. I cannot walk without a walker and have other cognitive neurological symptoms. I was discharged from hospital on 6/2/21 to sub-acute rehabilitation facility. I was discharged from rehab on 6/12/21. Neurological and neuromuscular symptoms are still present.

Shortness of breath, pain in chest, heart rate elevated for 2-3 weeks. 60-65 normal up to 92 after vaccine.

Shortness of breath; Chest pain; rapid respiration; weakness; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (at age of 60 years old) as single dose for COVID-19 immunization. Medical history included Kidney stone. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had Chest pain, shortness of breath, rapid respiration, weakness, increased heart rate on 12Mar2021 12:00PM. The adverse event result in: Emergency room/department or urgent care. No treatment received. The outcome of the events was unknown. This case Serious reported as No.

I started having pain in my lower back and shoulder. I had SOB. Pain in back that went up to my jaw. I went to the hospital. They did a cardiac work, came back negative for heart attack. The COVID-19 test came back negative. They did a chest CT scan to rule out PE. They show the I had COVID-19. I got swab the next for COVID-19, was negative. I still having SOB that is getting worse. They said I had a mild carditis.

Headaches the next day and tiredness, short of breath, had to go to the hospital unable to breath when laying down quizzing couldn't catch breath ER dx him with Cardiomyopathy. Had knot holes on his thyroid.

Asthma; My asthma symptoms reappeared; This is a spontaneous report received from a contactable consumer. This 60-year-old male consumer (patient) reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0153, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 21Apr2021 at 15:30 (at the age of 60 years) as dose 2, single for covid-19 immunization. Patient had known allergies to Plaquenil. Other medical history included asthma which he had since childhood and it was well managed with albuterol and Advair. He only needed it occasionally, generally in early spring and autumn. When he started taking prednisone/Medrol and Xeljanz for his rheumatoid arthritis in 2015, his asthma symptoms disappeared completely. He had been asthma free for the past 5-6 years. The patient received the medication within 2 weeks of vaccination tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis from 2015. Historical vaccine included he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 31Mar2021 at 15:45 (at the age of 60-year-old) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered at pharmacy or drug store facility. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01May2021, at 12:00 Am, the patient asthma symptoms reappeared. The Patient reported that a couple of months ago, his asthma symptoms reappeared, coincident with his COVID-19 vaccination in April. He took his first dose of the Pfizer vaccine at the end of March and stopped taking Xeljanz for one week, on advice of his doctor. He also stopped taking Xeljanz for 1 week after the second dose on April 21st. On 01May2021 at 12:00 AM, he started experiencing asthma again and he now needed to take Advair and albuterol daily to keep it in check. The treatment received for the adverse event included Advair and albuterol daily to control asthma. The events were reported as non-serious. The outcome of the events not resolved.

Runny nose.; throat closing (thickness); itchy throat; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in the left arm on 10Mar2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no concomitant medication within two weeks of COVID vaccine. The patient was not allergic to any medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021 at 16:45 (25 minutes after vaccination), the patient experienced runny nose followed by sensation of throat closing thickness, followed by itchy throat; which was possible to breathe through his nose. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event runny nose, itchy throat and throat thickness was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information expected.

wheezy; sob along with diaphoresis; shortness of breath; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: ER8727) via unspecified route of administration on 24Mar2021 (at the age of 60-years-old) as a single dose for Covid-19 immunisation. Medical history included asthma. Concomitant medications were not reported. During the 15 minutes waiting period after the injection the patient did fine. However, patient noted to be sitting on side after pushing his sister in wheelchair to take a "break." On 24Mar2021, the patient experienced wheezy, sob along with diaphoresis and shortness of breath. Patient had history of asthma and had forgot to bring inhalers. Patient does not walk much and was a long walk today and was offered a wheelchair and was brought to the bay for inhaler treatment. Patient denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures were taken as a result of wheeziness, diaphoresis and shortness of breath which include treatment with albuterol. The clinical outcome of wheeziness, diaphoresis and shortness of breath were unknown. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: 1. patient's last name updated. 2. Country added in patient tab. 3. leading sentence updated to a non-contactable other healthcare professional. Reported Event: During his 15 minute waiting period after the injection he did fine. However, pt noted to be sitting on side after pushing his sister in wheelchair to take a "break." He was noted to be wheezy and sob along with diaphoresis. Pt states he has hx of asthma and forgot to bring his inhalers. He normally doesn't walk much anyway and today was a long walk. He was offered a wheelchair and brought to the bay for inhaler treatment. He denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient complains of shortness of breath and wheezing Treatment included: albuterol

heavy wheezing; coughing; left side of back hurts; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration, in the left arm on 02Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux and seasonal allergies, and the patient was allergic to dyes, and a kind of antibiotic. Concomitant medications included bisoprolol celecoxib (CELEBREX), amphetamine aspartate, amphetamine sulphate, dexamphetamine saccharate, dexamphetamine sulphate (ADDERALL), esomeprazole magnesium (NEXIUM), and multivitamin (MANUFRATURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Apr2021 at 03:00, the patient woke up with heavy wheezing and a lot of coughs. He had tried and breathed shallow to not cough. Coughing lasted about an and couldn't controlled it. He took an over-the-counter allergy pill that seemed to help after about 40 minutes. He had to call in sick to work because excessive movement would get coughing again. It was reported that, at 11:00 he was breathing better. His left side of back was hurting from all the coughing. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. As the result of adverse events an unknown over-the-counter allergy pill was taken as therapeutic measure. The clinical outcome of the events wheezing, coughing and back pain were recovering. No follow-up attempts are needed. No further information is expected.

A few days after my second Covid vaccination I started experiencing fatigue, dizziness and shortness of breath. I also noticed the calf muscle in my lower right leg began to swell. The swelling continued to get worse and about a week later I noticed a significant amount of petechial hemorrhaging in my lower right leg. I started using an ice-pack in an attempt to reduce the swelling. I also sat/lay with my leg up (horizontal) as much as possible. On 6/28 I visited with my primary care doctor to seek help in addressing the swelling. My doctor sent me for an ultrasound which discovered a deep-vein thrombosis (DVT) and a CT scan which highlighted pulmonary embolisms in my lungs. I was admitted to hospital where I was treated with blood thinners; Note: I had my first shot on 4/13/21 and also experienced fatigue, dizziness and shortness of breath, but did not experience any swelling. As a result of feeling unwell I delayed getting my second shot.

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/30/21). Patient presented to ED on 7/25 c/o rash on his back, feeling generalized fatigue and weakness for last few days and had tested positive for SARS-CoV-2. Patient remained stable and was discharged from ED on same day. On 7/29 patient returned c/o headache and SOB, he was placed on 3.5L NC and given albuterol neb, acetaminophen and prednisone.

on 12/24/2020 I started feeling a little tired on 12/25/2020 I was feeling exhausted i had a cough and breathing problems, also had headaches & fatigue. I'm taking antibiotics for pneumonia Visited urgent care twice

headache, chills, injection site pain, feeling unwell, difficulty breathing, dizziness, weakness and imbalance

pulmonary embolism that presented with chest pain and inability to take a deep breath, admitted and started on Heparin drip. Patient transitioned to Apixiban.

All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting. Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair. Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583. Resident deceased upon re-check after calling PCP to report status change.

This is spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included Blood pressure high, Cancer (Two or less years ago; In remission, Taking medication to follow through with remission period), Allergies and sinus issues, covid virus (in July). The patient reported soreness in the arm (15Jan2021), fatigue (15Jan2021) and palpitations (16Jan2021) that he felt below the mouth and above the heart, calling it the esophagus area. He wanted to know if others had reported this same palpitation. The reporter further reported that he has a little bit of concern. He felt fine, had sore arm and fatigue that has gone away. Noticed lately, somewhere in his esophagus between his heart and mouth that he is feeling palpitations. Doesn't know if it's more indigestion. Stated it could be gas. Sometimes comes and goes, feels different than what he's already experienced. Wanted to double check if this has been heard of or anything similar to it. Clarified product as first dose of COVID-19 Vaccine. Received last Thursday. Received COVID-19 Vaccine in left arm on 14Jan2021 between 15:00 and 16:00. Both arms are sore, but only because other arm is injured. Pain level in injection arm was around 5-6 and he wasn't able to sleep on that side. Within the second day, 16Jan2021 in late afternoon soreness and fatigue was gone. Indigestion or Palpitations, feeling was happening again. They wanted to know if that is something he is experiencing from the COVID-19 Vaccine. Stated it doesn't appear to be related. It is around the esophagus. Stated it affects breathing. Stated maybe that has something to do with it. For the dose, they noticed it was a small amount of fluid in the tube that was injected into him. The outcome of the events soreness in the arm/sore arm and fatigue was recovered on 16Jan2021, while for other events was unknown. Information on the batch number/lot number has been requested.

Angina Narrative: Pt presented to the ED with persistent chest pain and shortness of breath for 6 days after receiving 2nd dose of covid vaccine. Symptoms began morning after receiving vaccine. Negative work up, however pt is high risk of cardiac events. Given ASA and nitro for ongoing chest pain that is possibly cardiac in nature. Pt admitted.

anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, "shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease." No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got "that shot" he hasn't felt well. When asked what shot pt replied "COVID shot." Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped.

Hives, Itchiness, Difficulty Breathing Benadryl and later when difficulty in breathing increased an Epipen Administered Symptoms Reduced, no further issues

1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER and was diagnosed with kidney failure & hyperkalemia, also positive for covid. Hospitalized till 1/13, underwent dialysis. Received 2nd vaccination 1/25, once again "passed out" in breakroom while at work. Pt was awoken after approx 1 hour, unable to move arm at that time, went home and did not seek medical care at that time. Pt was re-hospitalized on 2/2/2021 due to difficulty breathing & AMS. Dx with pneumonia & hyperkalemia at that time, discharged home 2/11/2021. Continues on hemodialysis 3x/week.

Approximately 10 minutes post vaccine patient complained of dizziness, shortness of breath and diaphoresis. Patient transported to ER for further evaluation.

Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at home when children noticed his lips were blue, ems arrived and found him to be 50% on RA, on Non-rebreather pt got to 78%, covid on 01/26 Shortness of Breath 61-year-old male presents with EMS for evaluation of shortness of breath hypoxia. History is limited due to the patient's current clinical condition and so is primarily obtained from EMS. EMS reports that he tested positive for COVID-19 5 days ago. He began developing shortness of breath yesterday and his family called because his lips and fingers were blue today and he appeared short of breath. On EMS arrival he had a room air saturation of less than 50% so he was placed on nonrebreather with improvement in his saturation to 70% and he was transported to the emergency department. Patient does admit to shortness of breath. He denies any chest pain. He is noted to have a cast on his left ankle and said that he broke his left ankle on 23 December but has not had surgery. He denies any new pain or swelling of the leg. In the ED he was placed on 15L nasal cannula and NRB mask with improvement in SPO2 to low 90s. Additional work up revealed troponin of 1.35, lactic acid 5.8, and d-dimer 14.4. He received dexamethasone and was placed on heparin gtt. 1/31 admitted to ICU Acute hypoxic respiratory failure due to COVID-19 vs heart failure vs PE. CXR with bilateral hazy infiltrates more pronounced in the bases and left periphery and suspected multifocal pneumonia. At risk for PE given LLE immobility in the setting of COVID-19 with significantly elevated d-dimer. RISK of CTA outweighs benefit given AKI and iodine allergy. Continue with empiric treatment with heparin gtt. Admitted to ICU with SO2 in 60s-70s on 15L and NRB. Attempted 50L 95% FIO2 high flow and nasal cannula. Given lasix 40mg IV with good diuresis however SPO2 still remained low 80s with RR 40s and PO2 42 so the decision was made to intubate. Oxygenation improved following intubation, with further improvement following recruitment maneuver and increase in PEEP. FIO2 weaned to 90% with SPO2 remaining in mid 90s. Will continue to wean FIO2 as able. ARDS net protocol as much as possible. Consider prone ventilation and/or epoprostenol if unable to improve . VAP Bundle: HOB >30 degrees; Oral care per nursing standard and on DVT/PPI prophylaxis Sedation: Target Richmond Agitation and Sedation Scale (RASS) of 0 to -2 with propofol and fentanyl. Check baseline TG levels. COVID - 19: Convalescent plasma: Not indicated Steroids: Dexamethasone 6 mg / day for 10 days Remdesivir: Not indicated d/t AKI IL-6 inhibitor: Meets criteria for tocilizumab Systemic AC: Heparin gtt. No signs of bleeding (Platelets and Hb stable). Antibiotics: Start 3 and 7 day course of azithromycin and ceftriaxone, respectively. Elevated troponin Suspect demand ischemia d/t hypoxia; EKG does not show any ischemic changes AKI: Suspect d/t hypoxia in the setting of COVID infection. Urine output and electrolytes acceptable. Closed fracture of left ankle Suffered fracture following a fall on ice in December. Cast was placed on 12/30 by SOS. He was due to be re-evaluated this week for possible cast removal. Inhaled epoprostenol started Considered for ECMO but not initiated due to not a candidate Vasopressors required at times Antihypertensive infusion required at times severe hypoxia with position changes switched from heparin drip to enoxaparin prophylaxis 2/20 discharge summary 61 y/o male admitted to Hospital on 1/31 with hypoxia. He was diagnosed with COVID 19 5 days prior to admission, and had worsening respiratory status. He was intubated after arrival, and was on ventilator for the entire intervening time, until he was extubated on 2/20 at the time of transition to Comfort measures only. Prior to developing COVID 19, he had received his first dose of the Pfizer vaccine, as a member of the school system. He had a fractured L ankle after a fall on 12/31/20, and had a cast in place at the time of admission. He received Tocilizumab on 1/31, and underwent several cycles of prone positioning, beginning on 2/2. He completed a course of Decadron, he received Ceftriaxone and azithromycin beginning on admission, and completed a course of these. Anticoagulation with enoxaparin was utilized due to coagulopathy associated with COVID 19. Vasopressor support was required at times, as well as diuresis for fluid management. He required high levels of sedation to maintain ventilator synchrony, and high levels of ventilator support with high oxygen levels throughout his stay. Tracheostomy was being considered, but family decided that since he was not going to have good recovery, withdrawal of support, and allowing death was the appropriate choice for the patient and for them. He was extubated at 2100 on 2/20/2021. Death was pronounced at 2123 on 2/20/2021. Children were at bedside.

Patient reported dizziness, headache, racing heart and mild chest tightness. Was evaluated by NP. HR in 80's. Lung sounds clear. Moved to private area for rest, water, snack. Encouraged to use his personal albuterol inhaler for his asthma. Repeat HR at his baseline 52bpm. Lungs sounds remained stable. Final pulse ox 99%. Observed for another 30 minutes. All symptoms resolved.

patient developed erythema at the injection site. he became nauseous and near syncopal. he then complained of chest tightness and DIB. Benadryl and two doses of epi given with no relief of symptoms. No facial swelling, wheezing, drooling, or hypotension. he was talking in sentences.

Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, disorientation, dehydration and consequently extreme anxiety from the incident. I was taken to an examination room at the vaccination clinic by their nurse director. Blood pressure was high and there was a question if I was having a stroke or heart incident. the director sent me by ambulance to Hospital as they didn't know if I was having an anaphylactic shock or cardiac incident. All this occurred within an hour if the first symptoms.

patient had his covid 19 vaccine. about 45 min to an hour later, at home, started to feel his throat closing. patient quickly took benadry and reported it helped. he then asked me what else he needs to do. I suggested he get checked out at the hospital and he went and got a prednisone and allegra prescriptions.

Patient had his first covid vaccine at 1340 and within 10 minutes the patient's neck began to swell, turn red and he felt like he was having trouble breathing. Rapid response called in building, Epi pen administered, Benadryl 50mg IM administered and pt sent to hospital via 911 ambulance at 1418

Patient received first dose of Pfizer COVID vaccine on 3/17/21. Around 3/19 or 3/20, patient started to feel fatigued with nausea, vomiting and diarrhea. He also developed fever, cough, and shortness of breath. He presented to the ER on 3/22 and was admitted to the hospital for supportive care and monitoring. Agency service was conuslted, and patient was started on COVID treatment with remdesivir and dexamethasone, and well as enoxaparin for VTE prophylaxis on 3/24.

Pfizer COVID-19 Vaccine EUA Pt received Dose 1 of Pfizer vaccine series 3/10/21. 3/21/21: A 61-year-old gentleman presented to the emergency room with increasing shortness of breath for 2 days. Patient reports mild nonproductive cough. Reports shortness of breath, worse with activities. He had his first dose of Pfizer COVID-19 vaccine 10 days ago. In the emergency room is noted to be hypoxic at 87% on room air, and now he is comfortable on 2 L of oxygen via nasal cannula, at about 94%. Chest x-ray suggestive of bilateral pneumonia. He is now testing positive for COVID-19. 3/26: The patient was diagnosed with moderate severity COVID-19 pneumonia and received Convalescent plasma and Remdesivir on March 21st and completed 3/25. He was on dexamethasone, doxycycline and pantoprazole. Initially D-dimer significantly elevated then trended down and the inflammatory markers trended down. The patient initially required 2-4 L of oxygen then improved and till he did not require any oxygenation today. His liver enzyme mildly elevated without disturbance in the liver function or kidney function. The patient will be discharged home on taper dexamethasone PO with pantoprazole for GI prophylaxis and follow-up with his PCP.

Patient presented to the emergency room 10 hours after receiving first COVID-19 vaccine with progressively worsening tongue swelling and minor shortness of breath. Patient received IV solumedrol, benadryl, pepcid and fluids. Patient's symptoms improved post treatment

Started with a severe runny nose. Runny nose and sneezing lasted approx 48hrs. When nose stopped running breathing got more laborious and a cough persisted. Slight fever and muscle aches for two more days. Trouble sleeping and cough started to produce mucus. It has been over 1 week since symptoms started and I am still experiencing coughing and mucus, as well as a loss of appetite. This was what I have experienced before when I have had a severe cold.

Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the face a fast heartbeat dizziness and weakness stomach pain

61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills. Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen. Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin. Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.

atrial fib; Short of breath; fatigue; Nausea; Dizziness; Unable to function; discolored; This is a spontaneous report from a contactable consumer(patient himself). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration, at Right Arm on 24Mar2021 12:30 (at age of 61 years old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Short of breath, atrial fib, fatigue, nausea, discolored, dizziness, unable to function, all on 24Mar2021 14:00. Adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Afib symptoms; short breath just walking doing simplest little things; Rapid heartbeat again; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:30 (Batch/Lot Number: EN6208), at the age of 61-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included Ankylosing spondylitis/psoriasis, cardiac ablation from Jan2017. The patient received dose 1 of vaccination on 28-FEB-2021 12:30 PM and was feeling small symptoms sometimes. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient started feeling small symptoms after the second dose, the next day, 22-MAR-2021 15:00, the patient definitely was having the Afib symptoms again, short breath just walking doing simplest little things and having rapid heartbeat again. The patient stated he had no problems before Pfizer vaccination. The outcome of the events was unknown. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19.

The next day I was very sick. It felt like someone had beaten me up. I spent most of the day lying down and drinking water. I tried to eat something and slept more. When I awoke, it felt like four huge needles piercing my lungs. I had to use my albuterol inhaler it was so bad. My symptoms are normally completely arrested by the use of Advair and Spiriva. The albuterol caused a dry heaving fit during which I expelled quite a bit of phlegm from my lungs. I felt better and the pain went away after that. Since then I've been suffering higher levels of chest congestion than is normal for me.

4/3 to 4/5: Fever over 101. General malaise. Extreme chest congestion and productive cough. 4/5 to 4/9: Difficulty breathing, congestion and sever productive cough continued. Chocking on chest mucus. O2 levels 89-91. 4/7: visited urgent care. EKG was irregular. Chest x-ray indicated needed further CT scan. Rapid Covid-19 test was negative. 4/8: Outpatient CT Scan. Indicated Interstitial Lung Disease. 4/10 to 4/12: Coughing and congestion started to clear. Extreme fatigue with any activity. O2 level starting to rise: 91-93. 4/13 to 4/15: Cough and congestion much better. Still some production. O2 level at 93 to 94 (95 - 96 with breathing exercises)

Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Nausea or vomiting Diarrhea

After an unannticipated time elapse after my first shot I experienced a throat irritation, then a need to cough, mucus and a wheezing, similar to that one would experience with pet dander, mold , etc. these lasted about an hour and a half and occurred about 36 hours after injection. Nothing in my life in that interval was different or unusual, neither diet, supplements, alcohol or environment.

Tongue swelling; could not process his breath; Could not swallow his saliva; headache; Nausea; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASL2021053617), license party for etanercept (ENBREL). This non-serious solicited report (USASL2021053617) was reported on 07/APR/2021 by a consumer from a commercial program (PSP00046b) and involves a 61 year old male patient who had headache [PT: headache], nausea [PT: nausea], tongue swelling [PT: swollen tongue], could not process his breath [PT: dyspnoea] and could not swallow his saliva [PT: dysphagia] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. The patient's concomitant medications included methotrexate. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. It was reported that the patient was using Enbrel for about five to six years. On an unknown date in MAR/2021, the patient received a recent injection of Enbrel. On 27/MAR/2021 at 10:00 AM, the patient received covid-19 vaccine. On the same day, the patient had nausea and headache but then it went away. On the same day at 05:30 PM, the patient had tongue swelling. The patient could not swallow his saliva and could not process his breath. Subsequently, the patient went to ER (Emergency room) and was started on Benadryl (diphenhydramine hydrochloride), prednisone and ranitidine. The patient was instructed by the physician not to receive a second dose of covid vaccine. The outcome of the events headache and nausea was reported as recovered/resolved. The outcome of the events swollen tongue, dyspnoea and dysphagia was reported as unknown. The events headache, nausea were resolved on 27/MAR/2021. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events headache, nausea, swollen tongue, dyspnoea and dysphagia. The causal relationship between the events headache, nausea, swollen tongue, dyspnoea, dysphagia and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for lot number. Causality Assessment: Events Swallowing difficult, Breathing difficult, Swelling of tongue and Nausea were assessed to be not related to etanercept.; Sender's Comments: Based on a temporal association and the known safety profile, the reported events are considered possibly related to BNT162B2. The events were unrelated to etanercept. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Difficulty breathing, like someone is choking me during inhale but no problems when exhaling. I didn't have this problem while recovering from my covid-19 infection earlier this year. I tested positive for covid-19 on Jan 26, 2021 but eventually got better after three weeks and was back working. I'm still back working but can't do much more than sit around, I have a desk job. Advil helps but the difficulty breathing comes back after a workout, running, walking up hill, lifting weights.

Blistering, wet rashes on legs; Rash and blisters affecting feet; muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine; Fever; Feeling unwell/Wasn't feeling good; Lost a lot of weight; Had to overuse inhaler; joint problems; Couldn't think; Affecting mental health; Blistering, wet rashes on legs; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 09Mar2021 (received at 61-year-old) as single dose for COVID-19 immunization. Medical history included arthritis, overactive immune system, unspecified mental health issues, and ongoing muscle pain. Concomitant medications were unspecified; the patient stated that he is on 4 vials of different medicine, or maybe 5. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), on an unspecified date for COVID-19 immunization. The patient reported that he had the Covid-19 vaccine. He reported that he was given a handout sheet that he read after he had the second dose of the Covid-19 vaccine. It was highlighted in yellow that he shouldn't have taken the Covid-19 vaccine with an overactive immune system. He further reported that the second dose of the Covid-19 vaccine is affecting his mental health. His mental health started being affected about 7-8 days after receiving the second dose of the Covid-19 vaccine. He stated that he is getting blistering, wet rashes on his legs again. He would like to see what he can do about this, but he will have to do it by mail. He reported that he has to get pictures taken of himself. He has an appointment tomorrow where he got the Covid-19 vaccine. He stated that he also has to go back to the dermatologist that is taking care of his immune system. He reported that he has lost a lot of weight. He reported that his weight is 147 pounds or maybe 141 pounds. He has lost a lot of weight since receiving the Covid-19 vaccine. He was given an emergency authorization release after he got the second dose of the Covid-19 vaccine. He noticed that he wasn't feeling good right away after getting the Covid-19 vaccine. When his legs started getting a rash and then blisters, his medical provider took pictures. The rash and blisters are affecting his feet too. The rash on his legs appears about 7-8 days after the second dose of the Covid-19 vaccine on 09Mar2021. He reported that what is on his legs started as rash and then turned into blisters. The blisters popped and it's like poison comes out. The fluid from the blisters smells, and that the fluid is ruining his clothes and is going to ruin shoes. The rash got worse the other day, with blisters forming. The blisters have now popped and there's going to be scars. The patient reported that he now has open wounds on his legs that bleed from the popped blisters. He also reported that it felt like all of his arthritis and muscles were affected. He took something for muscle spasms and arthritis, a muscle relaxant, for his back. Everything hit about the same time, 7-8 days after receiving the Covid-19 vaccine on 09Mar2021. The muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine. The patient also experienced joint problems, fever, feeling unwell on an unspecified date, had to overuse inhaler, couldn't think on an unspecified date. Outcome of affecting his mental health was recovering. Outcome of blistering, wet rashes on legs, muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine was not recovered. Outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Heart arrhythmia; shortness of breath; slight swelling of face and neck; slight swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534) via an unspecified route of administration into left arm on 21Mar2021 12:30 as single dose for COVID-19 immunisation. Medical history included heart disease, food and environmental allergies and diabetes. The patient's concomitant medications were not reported. On 23Mar2021 01:30, patient experienced heart arrhythmia, shortness of breath and slight swelling of face and neck. No treatment was given to the patient. Outcome of events recovered on an unspecified date.

On Friday, April 23/ 2021 @4PM I began to feel pressure built up on my chest. @ 4:15 the pressure also built up on my neck. I was short of breath and I can feel the heartbeat way too high. I recall the person that gave me the first Pfizer shot to get ready for side effects after the second shot. @ 4:30pm the pressure was all over the back, the chest and the neck. Making things worse the jaw and lower teeth were also in extreme pain. I laid down on the sofa and must have passed out. 20 minutes later I began to come around but I was way weak and the heart beat was beginning to relax. The body pressure was present till 6pm I did not know what to do at that time other than take a nap. I was not able to eat any food until Saturday 6PM.

Atrial flutter; Fatigue; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID-19 vaccine), dose 2 intramuscular, administered in Deltoid Right on 09Mar2021 (Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included Bladder issue, Elevated cholesterol, Elevated BP. Received BNT162B2 dose 1 on 16Feb2021 for COVID-19 immunization when he was 61 years old. Concomitant medications included rosuvastatin taken for Elevated cholesterol; losartan potassium taken for Elevated BP; oxybutynin taken for Bladder issue; tamsulosin taken for Bladder issue. The patient experienced fatigue on 12Mar2021, dizziness on 12Mar2021, shortness of breath on 12Mar2021, atrial flutter on an unspecified date. The patient underwent lab tests and procedures which included echocardiogram with atrial flutter on 05Apr2021, electrocardiogram with atrial flutter on 01Apr2021. After he saw the cardiologist, he was prescribed a betablocker and a blood thinner in the interim. He clarifies he was prescribed Metoprolol tartrate 25mg, twice a day. He was also prescribed Eliquis 5mg, twice a day. There were no additional vaccines administered on same date of the Pfizer. Events require a visit to physician office. prior vaccinations within 4 weeks was none. The outcome was unknown. No follow-up attempts are needed. No further information is expected.

Flushing, minor breathing issue, anxiousness occurring about 8 minutes after getting the vacciine. Patient admitted to anxiety discorder. Nurse and EMT assessed patient and obtained vitals. Patient got out and walked and stated that he felt better.

Pain in my chest ,swollen throat, light headed, dizzy, shortness of breath. sick for a week steroids, fluids

He is complaining of rhinorrhea, nasal congestion and a dry cough. He denies any fevers or chills. Patient said that he felt off yesterday. Since getting up today patient has felt more short of breath on exertion. He feels like he is breathing heavy. He is denying any chest pain or pressure. Patient did feel some pain behind his left knee over the last week, but has none at this time. He is also felt some mild right ankle discomfort, but that has resolved as well. He denies any recent COVID-19 exposures. Treated with heparin and catheter directed alteplase

chalky taste in my mouth; bad breath; stuffy and thus breathing issues; This is a spontaneous report received from a contactable Consumer reporting for herself. A 61-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:45 (Batch/Lot Number: EP6955) as single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced chalky taste in my mouth on 29Mar2021 with outcome of not recovered , bad breath on 29Mar2021 with outcome of not recovered , stuffy and thus breathing issues on 29Mar2021 with outcome of not recovered. No follow-up attempts are needed. No further information is expected.

after pt received 1st dose of covid vaccine, pt started having increased shortness of breath. he went to see his PCP and his PCP prescribed inhaler for him since his PCP thought it was due to his asthma exacerbation. but the inhaler didn't help. Shortness of breath worsened and pt started to have yellow/white phlegm. he came to ED for further evaluation. he was very hypoxic and tachycardic. per chart, he was noted to be mottled from his lower extremity up to his abdomen. BNP and troponin elevated.

sinus infection; couldn't breathe; extreme high anxiety; couldn't sleep; lack of appetite; nervous about everything; dehydrated; kidney levels numbers raised; headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 2 via an unspecified route of administration, administered in the right arm on 12Apr2021 at 11:15 (at the age of 61 years-old) for COVID-19 immunization. Medical history included blood glucose abnormal from an unknown date and unknown if ongoing other medical history: sugar, kidney problems, coronary artery disease (CAD), high blood pressure and renal disorder from an unknown date and unknown if ongoing. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 in the right arm on 22Mar2021 at 11:15 AM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medication for high blood pressure and "sugar medicine." The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 14Apr2021 at 06:00 AM, the patient experienced sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache. The patient was hospitalized for sinus infection for 1 days. The patient was hospitalized for couldn't breathe for 1 day. The patient was hospitalized for extreme high anxiety, couldn't sleep and lack of appetite for 1 day. The events sinus infection, couldn't breathe which led to extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache required an emergency room and physician's office visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021. Therapeutic measures were taken as a result of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache and included antibiotics and medicine to help sleep. The clinical outcome of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache were recovering. It was also reported that since the vaccination, the patient was tested for COVID-19. Information on the lot/batch number has been requested.

Pt complained of SOB. He had a normal pulse ox and RR. He was not exhibiting signs of angioedema or anaphylaxis.

having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Additional Details: patient's husband says pt was admitted to hospital with burning in chest, heart, throat swelling, anxiety and trouble breathing.

ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatment team Severe sepsis with acute organ dysfunction Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/10/2021 Admission Date: 4/3/2021 Length of stay: 6 Days PCP: MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Severe sepsis with acute organ dysfunction Yes Left hip pain Yes Primary osteoarthritis of left hip Yes Intractable vomiting with nausea Yes Acute metabolic encephalopathy Yes COVID-19 virus infection Yes Gastrointestinal hemorrhage with hematemesis No Urinary tract infection associated with indwelling urethral catheter Yes HPI: Admitted with severe left hip pain and altered mental status. patient with history of stroke Was also found to have Covid positive at the time of admission Hospital Course: Following issues were addressed during this hospitalization Acute encephalopathy: At the time of admission Most likely secondary to gabapentin Held medication during this hospitalization and also stopped at the time of the discharge. Patient was started on this medication recently due to his left hip pain. COVID-19 infection D-dimer was elevated at the time of presentation. CT chest ruled out pulmonary embolism. Ultrasound did not reveal any DVT. Patient did not qualify for any convalescent plasma remdesivir during this hospitalization as he is saturating well on room air. Possible catheter associated urinary tract infection Patient with chronic indwelling Foley catheter. Urine culture grew Staphylococcus hemolyticus and Enterococcus faecalis faecalis. Patient was started on ampicillin during this hospitalization he completed the 5-day course. Sepsis ruled out at the time of admission Acute kidney injury present at the time of admission Suspect underlying chronic kidney disease Patient needs to follow-up with the PCP for the follow-up on the creatinine in 1 week. Left hip pain Patient underwent extensive work-up during this hospitalization. MRI of the left hip showed high-grade tear of the iliopsoas tendon. Patient was seen by orthopedics recommending continued therapy and pain management. Acute GI bleed, presented as coffee-ground emesis Acute on chronic anemia Iron deficiency anemia Underwent extensive work-up during this hospitalization. CT angiogram of abdomen pelvis revealed suspected bleeding in the stomach. Patient underwent EGD which showed severe esophagitis most likely cause of the bleed. Gastroenterology recommending continuing pantoprazole twice daily. Patient hemoglobin remained stable during this hospitalization. Biopsy did not reveal any H. pylori infection. Patient was seen by PT OT during this hospitalization who recommended acute inpatient rehab. But patient and family decided to take the patient home patient was discharged home in stable condition with home health.

RASH ON BIL UPPER EXTREMITIES, SOB, CHEST TIGHTNESS, NUMBNESS ONLIPS, 10 MG ZYRTEC GIVEN PO, BENADRYL CREAM APPLIED TOPICALLY TO RASH ON UPPER EXTREMITIES AT 1:10 PM. EXTENDED MONITORING FOR 1 HR WITHI SYMPTOMS LESSENING. VITALS STABLEAT 137/87 BP, HR 76, RR 18, 97% OXYGEN ON ROOM AIR AT 1:50 PM. PATIENT ADVISED TO SEEK ADDITIONAL MEDICAL EVALUATION.

Patient reports throat swelling after first vaccination. He states he did not have trouble breathing but he felt like it was swelling. It went down after 30 minutes and patient was not administered epinephrine.

Dose #1 received on 4/21/21. Dose #2 received on 5/12/21. Difficulty breathing beginning on 5/5/28/21. Diagnosed with multiple blood clots in right lung on 5/30/21.

Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, cough, dyspnea on exertion and shortness of breath at rest, most symptoms are chronic but reports worsening with second Covid vaccine.

2 days after vaccine developed diarrhea & body aches, then loss of smell and appetite. ED visit 4/8/2021, lymphopenia noted, COVID PCR positive. Returned to ED 4/11/2021 with SOB, oximetry low 70s, cyanotic, respiratory distress, elevated D dimer, CXR: COVID pneumonitis. "Deteriorated quickly despite maximal medical management" per Discharge Summary. Died 4/24/2021 from hypoxic respiratory failure and multiorgan failure, shock. Had also developed heparin induced thrombocytopenia during treatment for DVT Right lower and upper extremities.

30 minutes after vaccination he did not feel good, has droopy eyes , slurred speech, numbness of left arm. high blood pressure, headach, shortness of breath 2 days after vaccination he feels better but still has mild headache , pressure behind eye, Rt eyelid ptosis, numbness of left upper arm and slight shortness of breath

I received my vaccine, I was monitored for 15 min with no effects. I walked outside to my truck when I got in I could not breathe, I was gasping for air. I am on 02 for my Copd and had to turn it up and sit for 30 minutes until I could drive because I could not catch my breathe. I lost my voice it is raspy and have had a COPD exacerbation since my vaccination. I have been hospitalized twice since receiving the vaccine, and still have no voice. No treatments are working.

My dad suffered what I believe to be a blood clot in his lung on April 6th, directly related to the second pfizer covid vaccination. Though chronically ill, he was not sick at the time, which was 4 days after the vaccine. He walked up the stairs, collapsed at the top, walked again to the chair, collapsed and then made his way into the chair where he told me "I can't breathe." and then slumped over. My mom and I lifted his limp body up and noticed he was not breathing. We moved him to the floor and started life support measures. About 5 minutes later the paramedics arrived. They were eventually able to get his heart and breathing going again about 14 minutes later. He was moved to critical care. After it became apparent he suffered irreparable brain damage, I stopped the life support measures (ventilator) and he passed away shortly after on Friday the 9th. They were continuously removing blood from his lungs while he was there. There was no indication he would die prior to this incident. Though we attempted to tell the critical care doctors about his recent vaccination, they were not receptive to the suggestion that this may have caused the incident that proceeded his passing. My mom did try the heimlich and there were indications that he had breathed in vomit, but he had stopped breathing before this and therefore his cause of death WAS NOT aspiration. He also had fallen the day after the vaccination (Saturday) and the notes indicated his broken ribs were from the CPR measures but this is in error as well as he had broken his ribs in the fall. It is my opinion the broken ribs caused a bruise in the lungs, the vaccination caused excessive clotting, and when he was coughing shortly before the incident it loosened the clots that then caused a pulmonary embolism.

breathing issues; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0185) at single dose for COVID-19 immunisation on 04Jun2021 (61-year-old at vaccination). Relevant history included Lyme Disease. Relevant concomitant drug was unknown. The patient previously received the first dose of BNT162B2 (Lot number: EW0176) at single dose for COVID-19 immunisation on 14May2021 with not reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced breathing issues on 04Jun2021. The event caused to Emergency room/department or urgent care visit, and the patient was hospitalized. The outcome of the event was not resolved. Unknown if treatment received or not. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.

Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty concentrating; Extreme sensitivity to sound; Vertigo; Dizziness; Earache; Anxiety; Chest pains; Chest stress; Spasms in chest and back; Began to get blur in right eye; Bowel movements changed; Numbness on face: lips, checks, forehead; Muscles have shrunk throughout body; Joints popping; Neck ache; Throat tight; Face and smile have changed; Hair is thinner; Hair gotten gotten more grey since these issues; Feet burning; numbness and tingling sensation in both legs to feet and both arms to hands and extremities; Back aching; muscle weakness; Brain fog; Fatigue - constantly feel like laying down; Difficulty Sleeping through night/Unable to nap throughout day; feet aching in joints; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0150) via an unspecified route of administration, administered in left arm on 30Mar2021 at 14:45 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included finasteride, ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride. The patient previously took augmentin s. On 03Apr2021 at 18:00, the patient experienced tinnitus/ringing/buzzing/chirping/humming in both ears, difficulty concentrating, extreme sensitivity to sound, vertigo, dizziness, earache, anxiety, chest pains, chest stress, spasms in chest and back, began to get blur in right eye, bowel movements changed, numbness on face: lips, checks, forehead, muscles have shrunk throughout body, joints popping, neck ache, fatigue - constantly feel like laying down, throat tight, face and smile have changed and hair is thinner. The outcome of the events was not resolved.

Intermittent SOB 5 days after the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Apr2021 (at the age of 61-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 15May2021 (Saturday), the patient received the second dose of bnt162b2. On 29Apr2021, the patient experienced intermittent sob 5 days after the first dose. Shortness of breath started getting severe on the following monday (unspecified date), worsened on tuesday (unspecified date), went to ED on Wednesday. He was diagnosed with CHF and experienced being unable to breathe when laying back in a chair and having to stop 5-6 times during a 1 mile walk due to the shortness of breath. He had been referred to a cardiologist. Caller had told there was a Pfizer program that can underwrite the cost of his treatment since it is related to the adverse event. The clinical outcome of the intermittent SOB 5 days after the first dose was unknown. Information on the lot/batch number has been requested.

Patient had several ED visits after receiving COVID vaccination; on 4/25/2021, 4/28/2021, 5/8/2021. On 5/12/2021 patient received second vaccination. More ED visits on 5/22/2021, 5/29/2021, 5/31/2021. On 6/3/2021 patient presented to the ED with shortness of breath and was subsequently hospitalized.

shortness of breath chest pain both would come and go i waited about 3 months before i went to hospital i would wake up in middle of the night hyperventilating got to the point i could not walk up a small hill with out going completely out of breath and forced to stop and try to breath

Short of breath 7/19, called EMS and arrived in ED morning of 7/20. While in ED became agitated hypoxic and apneic. Intubated. Diagnosed with PE and admitted.

PATIENT REPORTED A SORE ARM THE DAY FOLLOWING THE VACCINATION. THE PAIN SUBSIDED BY THE END OF THE SECOND DAY. ON DAY 4, THE PATIENT AWAKENED WITH FEVER, HEADACHE, BODY ACHES, CHILLS, SEVERE FATIGUE, SOB AND COUGH. ON MONDAY, JANUARY 4, THE WAS GOT FEELING ANY BETTER AND WITH TO SEE A PROVIDER AT MEDICAL CENTER. HE WAS GIVEN A CHEST X RAY AND LABS. HE WAS GIVEN A RAPID FLU AND COVID ANTIBODY PCR TEST BOTH NEGATIVE. HE DID NOT REPORT TO THE HEALTH DEPARTMENT AND THE HOSPTIAL DID NOT THINK FEEL THE SYMPTOMS WERE RELATED TO COVID VACCINATION. HEALTH DEPARTMENT ONLY FOUND OUT TODAY DURING F/U PHONE CALL WITH PATIENT. PATIENT IS RECOVERING AT HOME. AS OF TODAY, HE FEELS HE IS GETTING BETTER.

tingling in mouth and lips, some numbness followed, swelling/puffy feeling on throat under jaw, shivering. Throat and back of tongue started to feel swollen. Started on a benedryl drip and in about 20 minutes I started feeling better, chills stopped, throat improved. After 45min to an hour I went home. Received shot around 10am, symptoms started about 20min later. Received treatment 15 min after reporting symptoms. Took benydryl at 5pm, 9pm, 2am. Took tylenol at 5pm. Jan 6 woke up felling like a fever and minor tingling in mouth and lips. took benedryl at 7am. Slept through the night without symptoms. Taking a 25mg bendryl every 5 hours and ibprofen/tylenol alternating every 6 hours.

Angina Upper lip swelling/tickling and tongue tingling Narrative: 61 year old female with HTN and asthma with multiple allergies to meds and prior angioedema in past. Presented for her first dose of COVID19 vaccine; after the injection she felt her upper lip tingling and tongue. NO SOB, no throat symptoms, no change in voice, no rash, no hives. NO N/V. She did have some chest tightness. Diphenhydramine IV, famotidine IV, and methylprednisolone IV one-time doses given in ED with surveillance. Patient recovered, denied previous sxs, and was discharged from ED with a family member. ED physician note documents patient "will take" following medications at home (however no outpatient prescriptions found): Benadryl 50 mg po Q8H x 5 days, prednisone 40 mg po daily x 4 days, and famotidine 20 mg po BID x 5 days

Patient c/o Itchy rash over his abdomen, shortness of breath, itching inside his throat and feeling as if his throat was mildly closing. Patient received Benadryl 25mg IM, Solu-Medrol 125mg IV and Pepcid 20mg PO. Patient was sent out to ER for further evaluation. Patient returned from ER at 2349 with no new orders. ,No any acute distress reported.

Narrative: Patient was found to be short of breath with heart rate in the 140s. Initially he was thought to possibly be having an allergic reaction to the vaccine. For this, he received prednisone, Benadryl and famotidine. These medications did not improve his symptoms. He was then discovered to be in atrial flutter. He was admitted to the ICU for close monitoring. There he remained hemodynamically stable. He was treated with beta blockade that improved his heart rate and his symptoms. He was discharged to home the following day.

Right arm numbness that radiated to right side of the neck. Weakness headache and shortness of breath, difficulty swallowing.

19th vaccinated; my wife was exposed to COVID on 26th and she developed symptoms on 29th; I developed on 31st and tested Positive on January 2 for COVID; January3, I was admitted to ER for shortness of breath, my oxygen saturation - between 88 and 94; I was in the hospital and discharged on January 8. Remdesivir and Decadron treated with and also Eliquis. I was on oxygen until Wednesday (three days) and then I went home on 8th and continued on Prednisone for last week (Friday). Haven't gone back to work - shortness of breath, fatigue and headaches continue.

Patient reports having his flu vaccination in November 2020 and his Pfizer COVID-19 vaccination on 12/22/2020. 10 days later he noticed bilateral leg cramps subsequently leading to numbness in his feet, weakness in his feet, numbness on side of his legs, both hands and upper back. 2 to 3 days prior to admission on 1/2/21 he has noticed right-sided facial weakness andhas noticed increasing shortness of breath on exertion. He was initially seen by PCP who suspected Guillain-Barré syndrome and had a PFT done which showed reduced tidal volume and FEV1 He was seen by neurologistand had EMG nerve conduction studies which confirmed demyelination & patient has been sent to the hospital for IVIG treatment. Per PT note from 1/30: "UE ROM: WFL UE Strength: WFL, reports grip weaker from baseline LE ROM: WFL LE Strength: proximal WFL, ankle DF/ PF 2+/3-/5             Coordination: reports no deficits with finger to nose B Sensation: numbness B hands; B feet numbness and reports weight bearing feels like standing on something squishy Balance: WFL over level surfaces, able to compensate with strength Posture: midline Other: R side facial droop, able to close R eyelid Bed Mobility: mod independent Transfers: modified independent, no device; able to perform controlled eccentric lowering stand > sit Gait Level of Assistance: Modified independent, requires aide device or extra time Assistive Device: None Distance Ambulated (ft): 10 ft Gait: pt ambulating in room without device, appears mildly unsteady with decreased heel strike with increased foot flat contact, mild increased lateral postural sway (increased with retrowalk). No frank LOB. Stairs: verbally reports has been performing stairs sineonset of symptoms, stairs are hard but able to perform, improved with UE support when available, requires increased time and fatigues quickly Endurance: neuromuscular fatigue, requires increased rest breaks" He was admitted to hospital from 1/28-2/2 for 5 treatmens of IVIG. He had improvement of his SOB and numbness but has not had full resolution of symptoms.

Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient experienced body pains, aches, headache . Onn Tuesday patient had fever. Patient's condition progressively got worse. He had difficulty breathing by Wednesday night. He had low oxygen levels at 80 per pulse ox reading. Patient was coughing up blood. Family took him to hospital on Thursday morning due to breathing difficulty and patient died 2.18.21 at 10 am

The recipient was feeling well immediately after the vaccination, all day on 2.8 and in the morning of 2.9. His daughter in law text him at 0930 and he did not respond to the text (atypical) and then he missed a morning meeting. His wife was downstairs in a meeting herself and after the meeting was over she called to him and he did not respond. She found him with no pulse and was not breathing. She called 911 and attempted CPR. They did not complete an autopsy, they stated that they believe the cause of death was either an embolism, Heart attack or aneurism. The wife stated that she does not believe the death was due to the vaccination; however, there were no tests completed to prove or disprove.

Patient received the vaccine and was observed in the post vaccination area for 30 minutes. He then went upstairs to his apartment and returned approximately one hour later. He sat in the lobby and looked somewhat ill. He was questioned by house staff and said that he was ok. He then lost consciousness and slumped in his chair. Medical staff was notified and he was still unresponsive. He was lowered to the floor and upon assessment, he had no pulse or respirations. CPR was begun with bag mouth ventilation and subsequently chest compressions. He received 50mg of IM Benadryl and 40mg of Solu Medrol IM. He still had no pulse and he an AED pads were applied. AED analysis indicated a shockable rhythm and one shock was administered with return of pulse. He remained unconscious and ventilation was continued until EMS arrived.

After my vaccine, I went to the hospital because I experienced weakness some shortness of breath and some tremors. I am a doctor of training, one aspect the aspect of covid-19 affects testosterone. I got Covid after my first dose. I am still having some symptoms and scheduled to return back to work the third week of March 2021.

Patient was seen at Facility 10 minutes after his Pfizer immunization. He had wooziness, and hyperventilation with a breathing rate of 40. He was transferred by wheelchair to a stretcher. Initial Vitals: BP 128/68, O2 sat 96% on 2 liters O2, pulse 68; veteran was diaphoretic, with clear lungs. He did not recall he had an immunization, and was uncertain of his own age. He did report he was on metformin for DMII. 911 was called. He was transported to Hospital ER by EMTs.

Fevers, 101.9, body aches, cough, difficulty breathing. Still using Tylenol, vicks formula 44, albuterol, fluticasone propionate nasal spray.

03/07/21: Onset of dyspnea upon exertion 03/09/21: Worsening dyspnea and non-productive cough 03/11/21: Primary care visit for diagnosis/tests 03/12/21: Elevated BNP levels noted; chest X-ray 03/13/21: Further worsening of dyspnea 03/15/21: D Dimer test elevated (positive) 03/15/21: ED visit; CTA scan indicates pulmonary emboli (lots of clots); admitted to hospital; Heparin IV drip 03/16/21: (evening) Discharge on Eliquis 03/17/21: Moderately severe dyspnea upon exertion and non-productive cough continues Event: Pulmonary emboli

pulmonary embolism Narrative: Patient received first COVID-19 vaccine (Pfizer) on 3/2/21.Within 24-48 hrs patient had SOB. Patient went to ER & was Dx with unprovoked bilateral PE on 3/5/21. Patient has family history of VTE (father died of PE, mother had DVTs and was on warfarin). Patient was admitted from 3/6-3/7, discharged on apixaban. ID consult placed, ID physician recommended patient receive 2nd dose of COVID-19 vaccine in 21 days as scheduled.

Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unwell, fever headache, tiredness and injection site pain

Ringing in the ears, headaches, throat hurts when I breath in (swollen glands), shortness of breath, fevers, sweats, chills, jaw pain, sore body

Pt developed high fever and rigors 45 minutes after receiving 1st dose of Pfizer COVID vaccine. Presented to ED where he was found to have fever to 101.3, tachycardia, tachypnea, leukocytosis to 25, and lactate 6, meeting SIRS criteria. Pt was admitted and started on Zosyn, but infectious w/u completely unremarkable (neg BCx, unremarkable CXR, normal UA, normal abdominal imaging, no elevated LFTs given h/o cholangitis). He was observed for 24h off of Zosyn and did not develop any further hemodynamic instability or recurrent fevers and rigors. His WBC improved daily 25 -- > 11.5 -- > 7.1 and lactate cleared on night of admission with fluid resuscitation.

Became aware of individual when noted to meet the case definition for a Vaccine Breakthrough case. He is a resident of a facility who report he was brought to the hospital for respiratory complaints and tested Covid + at the hospital. Has a history of "underlying respiratory issues" per the facility.

Patient received the Pfizer Covid vaccine 1st dose. After the 15 minutes of observation, his wife notified staff he was feeling "dizzy and light headed". Patient stated he was having trouble breathing in his chest and thought he was having a little difficulty swallowing. EMS was called. Rph checked patient's BP which was 142/127. EMS arrived shortly after and took patient to ED.

episodic chest pain that began this morning (4/5). Pain described as a severe, sudden, fleeting "lightening bolt" that resolved after roughly one second. Associated SOA after episode that has resolved. No radiation. Residual chest tightness after episode. No diaphoresis, N/V, calf tenderness or edema. Potential improvement after taking antihypertensive medication and aspirin.

Patient stated that he experienced itching, swelling of the gums and tongue, and difficulty breathing about an hour and half after receiving vaccine. He reports going to Hospital ER on the Road where he was given Epinephrine, Famotidine, Benadryl, methylprednisone, Albuterol, and Racepinephrine . He was transported to the main hospital for further treatment.

'blood pressure had been up to 180/increase in blood pressure'; he was freezing; he was cold; ''he is usually up at work every day and he hasn't been able to work the last few days''; feels like he can't think'', ''tired; ''he may be getting in for breathing treatments today''; so sick; feels like he can't think'', ''tired; Feeling lousy; Lethargic; Running temperature; Chills; Hives; Anaphylaxis; fell asleep for 16 hours. Caller reported that he doesn't normally sleep for 16 hours; Throat scratching; Eye itching; Bags under eyes; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: EN6207), via unspecified route of administration on right arm on 19Mar2021 13:09 as a single dose, for COVID-19 immunization. The patient medical history included Ongoing COPD (about 5 years ago), high blood pressure (about 10 years ago and still ongoing) extensive allergies to food and insect bites. The patient was diagnosed with the allergies when he was a little kid, allergic to penicillin ongoing. Concomitant medications included lisinopril at 20 mg once daily in the morning for high blood pressure and albuterol at 2 pumps in AM and 2 in PM before going to bed for COPD (Chronic obstructive pulmonary disease). The patient previously took historical vaccine ampicillin for infection. On 19Mar2021, the patient experienced, ended up feeling really sick right after the shot. He has a lot of allergies and he was advised to take his Epi-Pen kit and stay an additional 30 minutes past the recommended waiting time after receiving his vaccine. His throat began scratching after getting the shot and lasted for about 3 to 4 hours for which the patient received Benadryl and resolved completely. His eyes were itching and lasted for 24 hours, and bags started to form under his eyes like anaphylactic shock. It was reported that the bags under his eyes would normally stay after anaphylaxis for a day or two. His eyes were still a little puffy at the bottom. He did not saw a rash but started to get hives, the paramedics were called and monitored him for another 30 minutes. The paramedics administered a shot of Benadryl. After the Benadryl was administered, his body and blood pressure started to come down. The paramedics reported that his blood pressure had been up to 180. It was reported that on 19Mar2021, afternoon, when the patient got home, he was sick, laid down and fell asleep for 16 hours. He does not normally sleep for 16 hours. He was unsure if his eyes were itchy in his sleep. Later in the call it was clarified that this might have only lasted 3-4 hours, he was so tired he just went to sleep. It was reported that he was not a sleeper, that he was usually up at work every day and he had not been able to work the last few days. It was reported that he started feeling the side effects of the Covid-19 vaccine at 13:20 on 19Mar2021. On 20Mar2021, he felt lousy ever since he received the COVID-19 vaccine. On the same day, his wife took his temperature, and his temperature was hovering around 100-100.9. He felt lethargic, running a temperature between 100.5 and 100.9 pretty consistent every day. On an unspecified date, his wife took his temperature, and it was 99.9. He felt like his mind was in a fog, intoxicated and he had not felt good since receiving the first dose of the Covid-19 vaccine. It was reported that the mental fog made him felt like he cannot think. The paramedics gave him a test and asked him to add 5+7. The patient answered 14, even though he knew that the answer is 12because he could not think, and he felt punch drunk. He reported that he can concentrate a little more, but he still felt drunk, this was hanging around the same now. It was reported that the paramedics were asking him questions and gave him things to do, addition and subtraction formulas, to keep his mind. He could not finish those formulas and that he told the paramedics that he felt foggy or punch drunk. He spoke with his health care provider at the VA and the provider advised him not to get the second dose of the Covid-19 vaccine. It was reported that the patient was inquired if he had any immunity to Covid-19 without taking the second shot and if he was protected with just the one dose of the Covid-19 vaccine. It was also reported that, the reporter also looked through the list of side effects for Covid-19 vaccine and it was like patient had all of them. The patient experienced chills, he was freezing, and he was cold. The patient had the whole list of them. It reported that he had doctor appointment on Monday, 29Mar2021, and that he may be getting in for breathing treatments today. He was waiting for his insurance to finalize the approval for the breathing treatments in the evening. The outcome of the events throat scratching and eye itching was recovered on 19Mar2021, Outcome of the events bags under eyes and blood pressure had been up to 180/increase in blood pressure were recovering. The outcome of the events feeling lousy, lethargic, running temperature and chills were not recovered. Outcome of the other events was unknown. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.

A day after covid vacine shot 7:00 am 4/9/21 ,I developed shortness of breath and fatigue. Then I developed a fever of 99.1 at 3:00pm that afternoon and O2 saturation was at 92 percent on 4/9/21. Saturday evening at 5:30pm I developed a fever of 99.4 and sereve fatigue and 89 O2 saturation level. Later that night at 9:00 pm on 4/9/21 my fever rose to 100.7 and O2 dropped to 85 when I tried to fall asleep. I took two puffs of an inhaler, two extra strength Tylenol and one Allegra D 12 hour tablet at 10pm. My fever broke at 1am on 4/10/21 and at 2am 4/10/21 my O2 stabilized at 92 percent saturation.

62-year-old male with number of medical problems that include history of hepatitis-C, history of cirrhosis, history of alcohol abuse, cocaine abuse, history of diabetes hypertension who has initially presented to EMS with increasing shortness of breath. Patient suffered cardiac arrest during his transportation to the emergency room. A CPR was initiated and was given 3 rounds of epinephrine. Most of the history is taken from the ER physician chart review. ACUTE RESPIRATORY FAILURE SECONDARY TO HYPOXEMIA, COVID-19 , cardiac arrest, possible anoxic brain damage : Patient is 62-year-old male with complicated history with history of hepatitis-C, cirrhosis, alcohol use, cocaine abuse diabetes who presented after having cardiac arrest and possible anoxic brain damage. Patient was intubated after the arrest. Patient stayed in the hospital for number of days. Patient was found to have COVID-19 positive. Patient was found to have diffuse bilateral infiltrate. Patient was started on broad-spectrum antibiotics including cefepime Flagyl and Decadron. Due to patient's cardiac arrest patient was started on hypothermia protocol. Patient was rewarming after that. There was no purposeful movement or neurological recovery. After long discussion with the family, patient has been made comfort care. Patient was extubated. Patient expired promptly after that. Family is notified.

Client reports feeling chest pressure, nausea and shortness of breath. Fire Rescue on scene to evaluate client. No resolution, Fire Rescue arrived for transport the patient to Medical Center for further evaluation at 10:00am.

Patient received 2nd dose of Pfizer Vaccine today at 2:32pm at temprorary vaccination Site Patient started C/O SOB, Abominal Pain, and Weakness. Patient states that the SOB and abdominal pain were experienced prior to vaccinations but got worse. Patient shared medical history of CHF, DM and Hypertension. Patient requested to be transported to the nearest ER. 911 Called by writer. Pulse Ox 98%, RR 20, BP 130/80. Temp WNL. Patient alert and responsive oriented x3. Patient Transported to ER.

patient's wife called 4-24-21 to inform clinic that patient was taken to the ER for "breathing issues and inability to walk"; was treated by ER and sent home

Patient woke up at midnight the night after receiving the vaccine and he couldn't breathe and was gasping for air. He called 911 and tried using the oxygen he has at home but it didn't help. EMS took him to the hospital where he stayed for 4-5 days. Patient reports he even stayed in the ICU for 2 of those days. He was on steroids, antibiotics, and oxygen during his hospital stay. He reports multiple physicians recommended that he not receive the second COVID vaccine due to this reaction.

Severe Leg pain (especially calves. Both legs equally) Major Leg swelling Elevated D-Dimer Low platelets Elevated Liver enzymes General Body Aches. Shortness of breath Fever Rash Fatigue / Malaise

Presented to emergency department on 4/7/21 with complaints of lightheadedness and feeling like he was going to pass out. He was found to be COVID-19 positive at that time and was deemed stable to return to home. Patient presented to emergency again on 4/24/21 with worsening symptoms of shortness of breath and coughing for past week. He was admitted for further management. He is still admitted at time of writing.

Pulmonary embolism, pea, heart arrest x2. 0100 4/14, some up with difficulty breathing. O2 sats low 80's and tachycardia low 100's. 4/15, says in mid 90's yacht at mid 120' s. 4/15 increased diffficulty breathing. Went to ed. Troponin in 800's. Saddle pe discovered on ct. Clots in rt leg found also. 4/16 is removed pe, ir decided to let clots in let reabsorb. 4/17, ready to d/c, when acute onset of respiratory distress occured. Went into PEA x 's 2. Back to ir to remove pe and place filter.

couldn't breath, gasping, inability to get up or get out of bed. lasted approximately 12 minutes then the gasping and labored breathing diminished and became easier to breath. after several more minutes, I was able to breath normally and could get up out of bed but couldn't walk without holding on to something. After a week my breathing is still shallow and my chest still feels "tight" at times.

Atrial fibrillation, dizziness, difficulty breathing, profuse sweating, pulse 110, very high blood pressure starting approximately 10 minutes after injection. Transferred to emergency room.

Very sore arm, fatigue, headache, then about 30 hours afterwards, extreme pain on right side under ribs, hard to breathe, went to ER, after several test performed, finding is PE in right lung and DVT behind right knee. I had signs of these weeks to months prior, have no underlying conditions before this happen, now I on Eliquis for blood clots! Also due to the blood clots have pneumonia!

This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (reported as "hypodermic needle"), administered in arm left on 25Mar2021 (Batch/Lot Number: EN6206) at age of 62-years-old as single dose for covid-19 immunization. Medical history included atrial fibrillation from Sep2016 (Diagnosis date: Sep2016). Concomitant medications included diltiazem taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for blood thinner, start and stop date were not reported; pravastatin taken for blood cholesterol, start and stop date were not reported. The patient received first shot on 25Mar2021. On 02Apr2021, the patient got shingles and his foot swelled up, his left side throat swelled up, the patient had shingles in his left arm pit and his left shoulder blade and now the patient do not get shingles. On his left armpit, the patient got a patch of shingles or hurting "roster" (not clarified) and also his left shoulder blade the patient got a patch and the same thing. His left foot swallowed up, it may or may not be related but it had appeared, had all appearances of very bad gout flare up, the patient couldn't walk in his whole foot and lower part was completely swollen, the patient didn't know this was related or not but the time being, the patient can't. The patient would like to report it and want to know. The rash on his body is still has but was subsided now, it was tolerable now. The patient was putting a topical cream on his armpit and shoulder. It was a burn cream, twice a day, it calls for at least twice a day. Outcome of the events was recovering. The patient got his bnt162b2 second shot (LOT#ER8729) on 15Apr2021. No follow-up attempts are needed. No further information is expected.

Hospitalization, on ECMO, deteriorating lung function - now on lung transplant list, hx. sarcoidosis. Question of whether vaccination caused worsening of lung function / sarcoidosis. Still currently hospitalized. Transferred to our organization for ECMO. Hospital Course: Patient is 62y.o. male with PMH of Sarcoidosis who presented to the hospital with worsening shortness of breath. Over the past 2 weeks, patient has had worsening shortness of breath on exertion and also while talking. On 4/23, patient noted intermittent fever, TMax 102F. Patient was seen by his PCP on 4/25 and started on a zpack, and was also seen in our ED on 4/25. He was discharged home with OP pulm follow up. Since then, patient has been feeling progressively worse, He noted 4/27, that his pulse ox was in the 70s with ambulation and that the cough and shortness of breath were worsening. In ER, patient has been placed on 6 L of oxygen via nasal cannula. He was also febrile with TMax of 101.5 F. POC COVID-19 testing was negative. WBC was slightly elevated at 10.7, Na level was noted to be 129. PCT was negative. CTA PE protocol was negative for PE, there was significant interval progression of nodular and consolidative opacities throughout both lungs when compared to 2017, compatible with interval progression of sarcoidosis. Patient was admitted for further workup and management. Patient's oxygen requirements gradually increased. He was initially treated with IV antibiotics and antifungals. He underwent extensive testing, including urine histoplasma, cryptococcal, respiratory viral panel which will negative. TB QuantiFERON was indeterminate, along with elevated IgM mycoplasma for which he received azithromycin. Patient was also placed on IV Solu-Medrol initially, transitioned to IV Decadron. Inflammatory markers were elevated. D-dimer was noted to be greater than 10,000, he was placed on therapeutic Lovenox dosing. Patient did have Covid testing which was negative, he was also vaccinated. His oxygen requirements continue to increase, he was eventually placed on BiPAP, although due to lethargy and increased work of breathing patient was eventually intubated and sedated. He was also started on paralytics. Patient was transferred to another hospital for possible need of ECMO or lung transplantation.

Acute trouble breathing followed by fainting/loss of consciousness. Chest compressions were started as paramedics were on the way. Paramedics worked on my dad for over 30 minutes but were unable to revive him. They stated he went into cardiac arrest.

Upper respiratory tract something going on; possible bronchitis; Left lower lobe atelectasis; D Dimer that was positive, reading 1.95; Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 21Jan2021 07:30 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included psoriatic arthritis from 10 years (he started Cosentyx three or four weeks before reporting) and COVID virus from Nov2020. Concomitant medications included secukinumab (COSENTYX) from three or four weeks before reporting for psoriatic arthritis. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at left arm on 31Dec2020 07:30 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. Prior vaccinations within 4 weeks was none. Patient states he just wanted to report; and he didn't know if this is significant. Patient reports now he has bilateral pulmonary embolism (from 04May2021) along with an upper respiratory tract something going on. Adds he never had this before. The doctor for his possible bronchitis has him on Omnicef and started Xarelto. Adds they were lucky to find the pulmonary embolism. Mentions the doctor tried a different antibiotic first, Keflex (NDC 68180 0122 02), and it was not helping. The doctor noticed his pulse oximeter (on 04May2021) reading was 92% and did a chest x ray. The chest x ray (on 04May2021) showed left lower lobe atelectasis. The doctor said that would not account for the low pulse oximeter of 92%. She sent him for a D Dimer (on 04May2021) that was positive, reading 1.95; and then had a chest CT at 1:00PM on Tuesday (04May2021), that showed the bilateral pulmonary embolism. Adverse events required a visit to physician office (received outpatient tests). Therapeutic measures were taken as a result of the event possible bronchitis and included Omnicef and Xarelto. The outcome of the events was unknown. Information on the lot/batch number has been requested.

past history of diabetes, hypertension, hyperlipidemia and recent diagnosis of COVID-19. Apparently the patient received his initial dose of COVID vaccine on 03/31/2021 and subsequently developed loss of taste and smell. He was tested for COVID-19 at local Pharmacy and received notification that his result was positive. He subsequently had improvement in his symptoms and was retested 2 weeks subsequent with negative results. On for 01/20/2021 he received his 2nd COVID 19 vaccination and subsequently developed recurrence of feeling ill 2 days afterwards. He progressively had feeling of shortness of breath along with nonproductive cough. The patient then developed complaints of chest pain and rib discomfort. He presented to the emergency department where he was found to be hypoxic along with abnormal labs including a creatinine of 1.84 BNP of 12,699, elevated transaminase levels, hemoglobin of 8.9. Chest x-ray showed patchy airspace disease to the right lung consistent with COVID-19 pneumonia. At time of admission he was given IV Lasix and started on Rocephin and Azithromycin. The use of steroids as well as any antiviral treatment was withheld because of presumptive symptoms related to bacterial pneumonia (secondary to COVID 19.) He also did not require oxygen supplementation during his stay.

Fatigue, unspecified type Dizziness Fever, unspecified fever cause Weakness COVID-19 virus infection Office Visit 5/12/20Family Practice PA Family Medicine COVID-19 virus infection +4 more Dx Cough Reason for Visit Progress Notes (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 5/12/2021 Cosign Needed Expand AllCollapse All Assessment/Plan TENT. 1. covid positive - symptoms and diagnosis occurred x15 days ago. He was improving but starting yesterday he has developed R sided chest pain and has been slightly SOB. Cough has worsened as well. He has not been taking ASA, will rule out PE at this time. STAT chest CTA ordered, CBC, and CMP. Possibility of secondary pneumonia but will hold off on abx for now, review after chest CTA results. Continue Acetominaphen and hydrating. If any symptoms worsen or the following occurs go directly to ED; fever/chills, chest pain, SOB. Patient understands and agrees. If chest CTA rules out PE and shows pneumonia would cover w/ azithromycin/ceftin/prednisone. Diagnoses and all orders for this visit: COVID-19 virus infection - CBC; Future - Comprehensive metabolic panel; Future - CT angiogram chest pulmonary embolism with and without contrast; Future Fatigue, unspecified type - CT angiogram chest pulmonary embolism with and without contrast; Future Other chest pain - CT angiogram chest pulmonary embolism with and without contrast; Future Tachycardia - CT angiogram chest pulmonary embolism with and without contrast; Future

Day after 2nd dose, discomfort stayed in bed. 2nd day after dose shoulder pain radiating to chest, during night intense chest pain with extremely shallow breathing. By morning chest pain so bad I went to E.R. I was admitted with normal EKG and oxygen levels. Elevated test that indicates blood clot in lung. CT scan done. Diagnosis Pulmonary Embolism. Was admitted to hospital for 2 days while undergoing heparin and warfarin therapy and pain relief. Prescribed blood thinners for 6 mos. After release severe fatigue and low HGB levels limited walking of more than 50' without losing consciousness. It has been 1 month and still can only walk 100' without lightheadedness.

shortness of breath; Fever 100 +; left arm pain; malaise/feel sick; headache; feel sick and tired; This is a spontaneous report from a contactable other Health Professional (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 14:45 (Batch/Lot Number: Unknown) at the age of 62-year-old, as 1st dose, single for covid-19 immunisation. Medical history included covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. There were no concomitant medications. The patient previously received other Pfizer vaccine (unspecified name) on 27Apr2021 administered in left arm for immunisation. The patient experienced shortness of breath, fever 100 +, left arm pain, malaise, headache, feel sick and tired on 19May2021. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event shortness of breath cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.

The AFIB occurred around May 5th and it was continuous almost the whole month of May. Shortness of breath, tiredness and interference with my daily interactions. I would get tired about 30 minutes of anything. Whatever the medical term is for when you get tired easily, shortness of breath etc. Just basic AFIB symptoms. The Dr gave me Solital 2x per day and as soon as he did that, within two days the AFIB went away. He took away my blood pressure medication and gave me the Solital. But I still get tired easier than I did before.

Diabetes; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; He said it feels like a bug is eating inside or by his head; This is a spontaneous report from a contactable consumer (Patient's daughter). A 62-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732; Expiration Date: 30Jul2021), via an unspecified route of administration on 29Mar2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient previously took first dose bnt162b2 (BNT162B2, solution for injection, lot # EN6199 expiration date: 30Jun2021), via an unspecified route of administration single for covid-19 immunisation. It was reported that, the caller is the caregiver of the patient, her father. The caller was called to report an adverse event from the Covid-19 Vaccine. The patient received his second dose of the Pfizer covid-19 vaccine at the end of March. The patient's neck has been hurting, his back has been hurting on the left side and his lung has been hurting. It felt like a bug is eating inside or by the patient's head. The patient was diagnosed with diabetes a couple of weeks ago. The caller clarified and confirms that the patient was diagnosed with diabetes 1-2 weeks ago. The patient has had the pains for a while now, he got the second dose around 29Mar2021. The patient's neck that has been hurting is the same but getting worse. The patient's lung pain comes from time to time. The caller later clarifies and confirms that the patient is 62 years old, not 61 years old as previously reported. The outcome of the events was Not recovered. Follow-up attempts completed. No further information expected.

Pt states month after 2nd dose chest tightness, sweating, fatigued. Since then no breath, low energy. Feels like his heart is pounding out of his chest. Doctors ordered stress test, Ekg 04/28/2021. Extreme mental state stress.

Fatigue and swelling with joint inflammation in left extremities. Follow-up for polyarthralgia Brief history: Probable reactive arthritis: One week after getting second COVID vaccine (Pfizer, 5/3/2021) he developed chills, sweats, SOB, cough and red/watery eyes. Initially given topical antibiotics for eyes in walk in clinic. Went back and on 5/17/2021 given Medrol dose pack which cleared up symptoms. From 5/10/2021 onward he developed left shoulder soreness and limited ROM. He has had persistent polyarthralgia with morning stiffness. Seen initially in June 2021 with noted joint effusions in left elbow and left knee. Evaluation around that time significant for positive ANA (1:160, speckled), RF (22, normal < 14), SSB, Scl-70 (weakly positive). Other ENA panel and CCP negative. X-ray of left shoulder (6/3/2021) showed only mild degenerative changes suggestive that the limited ROM in shoulder is related to frozen shoulder. Rheum Medications: Celebrex 200mg daily Doxycycline 100mg daily (started about 2 weeks) Interval history: Patient was last seen 6/3/2021. He reports that the swelling in the left calf has decreased. The left knee has been bothering him. The mornings are the worse time of day. He continues to have swelling in the left knee. He has been doing ROM exercises with the left shoulder. At night he is not sleeping because of pain. He has morning stiffness which lasts from 20-30 minutes. He has noticed some pain in the left thumb. No eye pain/redness. No rashes. As in HPI, otherwise 12 point ROS was reviewed and negative

63 year old male patient presents to ED 6/25/21 reporting 5 weeks of progressive cough, dyspnea and intolerance to exertion that has become steadily worse despite supportive therapies. He reportedly completed outpatient ABX from PCP within the past 2 weeks and suffers ongoing deterioration of his breathing accompanied by night-sweats, chills and fever. 1st Vaccine on 5/27/21, 2nd 6/17/21. hypoxemia secondary to large left sided pneumonia.large left sided effusion with compressive atelectasis and question of infectious vs malignant origin.acute hypoxemic respiratory failure requiring HFNC. Patient admitted to the ICU on our service for ongoing care.Hospital Course:Mildly elevated BNP and non-diagnostic EKG.Findings consistent with bilateral pneumonia, large left complex parapneumonic effusion versus empyema with compression of left lung and evidence of external impingement on LV. Systolic blood pressures ranging in the 80s to 90s with MAPs ranging from mid 60s to mid 80s with heart rates in the 90s, which may be attributed to diminished LV filling. Transferred 6/26/21.

Nausea, vomiting, pasted out twice at the pharmacy, Dizziness, Muscle Weakness, Shortness of breath, chest pain and tightness.

Pt presented on 6/16/2021 complaining of shortness of breath and difficulty breathing, worse with exertion or lying down. He was directed to the emergency room, admitted, and subsequent tests revealed Severe Stenosis of the RCA and Non ischemic Cardiomyopathy. During his hospitalization, the cardiologist Dr. mentioned to the patient that his illness may be connected to his Covid vaccination and advised patient to report his symptoms through the VAERS.

Shortness of breath; Body aches; Pain; Headache; Nausea; Muscle pain; injection site pain; fever; feeling unwell; swelling of throat; weakness.; This is a spontaneous report from a contactable consumer. A male patient of 62 years age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE LOT number UNKNOWN) On 21Mar2021 16:30 via an unspecified route of administration, on the left arm as a single first dose (at the age of 62 years) for Covid-19 immunization. Patients medical history reports bronchitis, COPD, asthma and oral cancer from 8/01 and operation/recovery/radiation till 11/01. The patient reports allergy to penicillin, nuts. Prior to vaccination patient has was not diagnosed with COVID-19. Since vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received doxycycline(UNKNOWN MANUFACTURER), metronidazole(UNKNOWN MANUFACTURER), guaifenesin(UNKNOWN MANUFACTURER), aspirin(UNKNOWN MANUFACTURER) within 2 weeks of vaccination. On 22Mar2021 patient reports to have shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The patient also reports to have a compromised immune system due to oral cancer. No treatment was taken as a result of the events shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.

Extremely high sugar levels; Shortness of Breath (am COPD to begin with); flu-like symptoms; Malaise; Chills with no fever; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot Number: EN6198, expiration date not provided) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 02Mar2021 at 08:00 AM as DOSE 2, SINGLE for COVID-19 immunization. The medical history included chronic obstructive pulmonary disease, diabetes mellitus, coronary artery disease, and reaction to preservatives (known allergy: Food sulfites (MSG)) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL9269) administered in Right arm on 12Feb2021 at 08:00 AM for COVID-19 immunization. There was no COVID prior vaccination reported. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. On 03Mar2021 at 03:30 AM the patient experienced extremely high sugar levels, shortness of breath, flu-like symptoms, chills with no fever and malaise. It was reported that extreme onset of flu-like symptoms almost 20 hours after shoot. Chills with no fever. Shortness of Breath (am COPD to begin with). That relaxed after about 12 hours, but SOB continued. General malaise continued for a few days. Extremely high sugar levels persisted for a few days, readings over 500 and once even over 600 which is rare for me (diabetic). The patient underwent lab tests and procedures which included blood glucose increased: 500 (over 500) and blood glucose increased: 600 (over 600) on 03Mar2021. No treatment was received for the adverse events. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in right arm on 30Mar2021 09:30 (at the age of 62 years old) as dose 2, single for covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The most recent COVID-19 vaccine was administered in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (lot number EN6206) as Covid-19 immunization on 09Mar2021 9:30 am (at the age of 62 years old) administered in the right arm. On 19Apr2021 21:00, the patient experienced congestive heart failure, fluid buildup in lungs, enlarged heart, and palpitation in beating of heart. The events were reported as serious, hospitalization on unknown dates for 4 days, disability, and were life threatening. Adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken in response to the events which included unspecified medicines. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events reported was not recovered.

Patient calls with report of irregular heart rate, shortness of breath, chest congestion, sinus congestion, loss of smell. There have been three positive COVID cases at his work. He is full vaccinated. Reports hx of afib.

62 year old male presented for 1st dose COVID vaccine with pfizer. 15-minutes post-vaccination the patient complained of having a minor headache. At this time he expressed no other concerns or symptoms. The patient was moved to a shaded area and provided water. Upon further questioning in Spanish the patient reported that his HA was progressively worsening since onset and he had an associated "tightness" and sensation of a growing lump in his throat. Patient denied SOB, chest tightness, difficulty breathing, itching, hives, lightheadedness, N/V. At this time the decision was made to contact EMS. EMS arrived at 1804 and evaluated the patient. During evaluation the patient reported improvement of his HA and throat discomfort. EMS instructed patient to be evaluated at the local ER. However, the patient refused and signed to leave AMA. Patient left the site at 1825 and stated he would take the bus home. Education was provided and patient instructed to follow-up in ER if symptoms re-emerge.

sore throat, runny nose, headache, shortness of breath. Stated started on January 5, 2021. Reported to staff 01/15/2021.

Shortness of breath started 1/16 in the AM, worse when lying down. .Also had diarrhea and a rash on right lower extremity. Discharged from ED to home. No significant findings found on work up.

Shortness of breath - Initial ED Comments: Patient is a 63 y.o. male patient presenting to the ED via EMS with c/o shortness of breathin which began this morning. EMS reports that the pt had a bilateral lung transplant 1 year ago and has been on cyclosporine and cellcept. EMS also reports that the pt recently received his COVID vaccine. Pt denies fever, chills, chest pain, abdominal pain, back pain, nausea, vomiting, or lower extremity edema. EMS reports that the pt does not normally require supplemental O2 but states that his O2 sat was 75% on 3 L NC home O2. EMS reports that they gave 2 albuterol, 1 Atrovent, and solumedrol. EMS also reports that they placed the pt on 10-15 L NRB and states that his O2 sat was stable at 100%. Pt denies any aggravating factors for his symptoms

States two days prior to vaccine he first noticed a fever blister. Reports since receiving first vaccine dose last Friday (2/26/21) he has not been feeling well, notes swollen eyes (lid overlap eyelashes), eyes wet/watery constant, swollen throat, face swelling, and fatigue. Reports this has improved somewhat. Denies any pain/injection site reaction from vaccine.

About 10 minutes after receiving vaccine the patient developed tightness in his throat,anxiety,redness in face and hands and shortness of breath.The patient was given epinephrine 0.3 mg intramuscularly in his left lateral thigh at 11:10 am.The patient responded nicely to the epinephrine and vs at 11:20 were bp 138/68,pulse 102,pulse oximeter 95%.His treatment occurred at the vaccination site. He then was transferred to our local emergency room and was observed for 2 hours.His symptoms abated and he was discharged. He informed us that he had received a moderna vaccine on 01/28/2021 without complications.We learned this after his vaccination.

Immediate swelling at injection site (~0.75" high). 30 hours later experienced extreme shortness of breath with rapid onset wich lasted for 3 hours. Next 3 days extremely tired to the point of barely being able to get out of bed. Following 4 days, very short of breath after climbing one story of household steps. Currently, very low endurance before running out of breath.

Patient recived first dose of Pfizer COVID vaccine on 3/18. Patient admitted to hospital at later date. Patient was complaining of difficulty breathing and exacerbation of ALS symptoms. Patient tested positive for COVID in our ER. Patient was also enrolled in trial evaluating experiment drug for ALS. Medication is called Zilucoplan. Patient did not qualify for any COVID specific treatments. Patient did receive antibiotics. Patient was discharged in stable condition with plans to follow up with his ALS treatment team.

1st shot (3/11/21) - headache, muscle aches, shortness of breath, fatigue, began the day after the shot and are still ongoing, using over-the-counter medications - ibuprofen and acetominaphen 2nd Shot (4/1/21) - Same symptoms but the headache, muscle aches and shortness of breath are much worse. Still using OTC medications.

Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which had gotten worse over the day 4/3/21. He had a rash all over his body.. After the respiratory treatments failed, pt was intubated and transferred to a higher level of care and expired on 4/4/21

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: SOB from 48 hours post vaccine to present-Severe, Additional Details: 6'2\" 235lb adult male with no history of SOB reports abrupt onset of SOB 48 hours post vaccine to present (19 days later) with exertion, walking or talking. Physician reported neg for covid and normal EKG. Refered to cardiologist to continue investigation. Told to hold second dose.

After patient took the first shot for 2 weeks, he suddenly could not breathe and hold his hist very tight in the morning while he was sleeping. My mom tried to wake him up, and he woke up and thought he was dreaming. He was fine during that time and we did not realize it might be caused by the vaccine. However, after patient took the second shot of the vaccine for 2 days, he suddenly could not breathe again and hold his fist very tight and bite his teeth very tight while he was sleeping. We try to do the CRP for him right away and called the ambulance at the same time. We try to wake him up, but he had no consciousness. And we realized that it might be the vaccine's problem.

Resident passed on 3/23/2021. Resident continues to decline medically. 2/22 He was admitted to nursing home with worsening pressure injury.

Acute right lower lobe subsegmental pulmonary embolism. Patient presented with right-sided, intercostal chest pain and shortness of breath. CT angiogram revealed a PE with small infarct, no heart strain. Patient started on pain medication and anticoagulation. Anticipate full recover and discharge the day after hospital admission. This is hospital day 1.

Took my last shot of Pfizer on 4/10/2021 at 10:00 AM and on4/12/2021 started having shortness of breath,tiredness, and chest pains this continue on until 4/15/2021 while I was at work at 6:15 PM my wife had to be called to come pick me and take me to the hospital where they did a Cat scan and discovered that I had Blood Clots In both Lungs and had to remove them at that time in order to save my life

Chills, Fever, Chest Pains, Lungs Hurt to Breathe, Extreme Weakness, Joint Pains and Burning, Heart Racing, Headache, Neck Pain, Diarrhea, Slight Swollen Thyroid. Arm Soreness With my first shot, all I had was a sore arm for 4+ days. The second shot I has diarrhea the day before going to be only to wake up in the middle of the night with all of the above symptoms at 4:00 AM, By Noon that day, I was fatigued but able to go to work. A week later, I had chills again and lost my taste and smell which I had a majority back from having COVID-19 3 months earlier.

Developed shortness of breath and exertional chest pain within 24 hours of vaccine. Ended up having NSTEMI and 3 vessel CABG a week later. Will attend cardiac rehab

help knock pain down for joints hurt like heck; a pinching like pins and needles trying to get out on your stomach area, it comes and goes; first time the rash itched underneath; Like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes; Like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes; Started freezing all over the place, hands are ice cold; Starts effecting different joints in the body, hit the muscle or joint; Starts effecting different joints in the body, hit the muscle or joint; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Started freezing all over the place, hands are ice cold; a little pain in the muscle; A paramedic gave vaccine and hit an artery; bleeding underneath skin above injection site, 7 droplets of blood above injection site; When stood up couldn't breath and throat was like closed off; When stood up couldn't breath and throat was like closed off; Severe sharp pain in your head that comes and goes each day to this day; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EN6208 and expiry date not provided) via intravenous, in left arm in shoulder area on 18Mar2021 (at the age of 63-years-old) as a single dose for covid-19 immunisation at hospital. Appointment was for 8:40, told facility he had allergic reactions to allergies. Medical history included patient had life and death lung surgery in 1997, lost bottom lobe on lung, less breathing capacity than normal person. There was no relevant family medical history. Patient was told by family doctor, should get the Covid shot. Concomitant medications were none. Patient did not have prior vaccinations within 4 weeks. No additional vaccines were administered on same date of suspect vaccine. There was no investigation assessment. AE(s) following prior vaccinations: Patient stated it was not like this, usually just sore arm where put needle in, never had blood fly out of arm on rubber glove, or bleeding, after pulled syringe out, kept pressure on arm. Patient has never had anything like that happen. Patient did not provide NDC/lot/expiration for vaccine that made arm sore where put needle in. Never happened again after that. On 18 Mar2021, a paramedic gave vaccine and hit an artery, and injected the vaccine into his blood stream, when stood up patient couldn't breath and throat was like closed off and bleeding underneath skin above injection site, 7 droplets of blood above injection site. Patient still has one today that didn't go away yet. Patient stated that he suggested to the Paramedic that he pull out the needle and put it in the right arm and start over. Paramedic was just staring at the blood coming out underneath the syringe and continued to shoot the first dose Pfizer Covid Vaccine into the blood stream. After a few seconds caller's throat opened back up. States it was freaky. Never had that happen before. Throat opened back up, but scared patient real good. Just happened for a few seconds after standing up, maybe patient stood up too fast and that caused the problem. When patient got home he had blood on his arm and shirt. On 29Mar2021 11th day after first dose Pfizer Covid vaccine, patient experienced like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes, also patient started freezing all over the place, hands are ice cold, was wearing long johns two sweatshirts and a winter coat in house to be warm. Patient puts hands in coat pocket to warm up. This is still going on every day, still going on this morning. It started effecting different joints in the body, hit the muscle or joint, joints targeting on and off, still happening every day, No effect on joints yet. Patient hopes does not have anymore.. First symptom started after first dose Pfizer Covid vaccine, for seven days underneath the muscle. It was that 20 minutes one time it showed up. Patient clarifies that this began on the 7th day after receiving the first dose Pfizer Covid Vaccine. Patient had a little pain in the muscle. Felt something in the muscle are for about 20 minutes. It was ongoing and persisting. Also had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit. It was a pinching on the inside trying to come out through the skin. That's what the rash feels like. Reports this was still coming and going. Clarifies the rash underneath the right arm and on the chest is what patient was referring to. Last night for first time the rash itched underneath patients right arm in the muscle, it started to itch, still hot. It was never itching before but started itching last night, 20Apr2021. Rash came back on right arm between elbow and shoulder in muscle area. Red rash came, felt the pinching like trying to come out from under the skin. Patient went to the bathroom and looked and it was itchy for the first time. Patient didn't want to itch it, rubbed lightly with flat hand so nothing would happen. Improve a little bit, not all over chest like it was, going on in different locations of the body. On 20Apr2021, patient having a symptom from yesterday and today a pinching like pins and needles trying to get out on your stomach area, no rash there but it comes and goes. Patient pushes finger on it and it seems to calm it down a little bit. Reported this was another symptom that was appearing. Patient states he was still having these symptoms. On an unknown date in 2021, patient experienced severe sharp pain in head, he has a stabbing pain in forehead that comes and goes each day to this day. After that started experiencing, never had headaches before, that was a severe sharp in your head that comes and goes each day to this day. Treatment received ibuprofen 300mg once in a while to help knock pain down for joints hurt like heck. Patient doesn't know when he began taking, after symptoms occurred he began taking. Other than that the patient did not take it. Patient was not a big fan of taking medication. No relevant tests were done. Patient visited emergency room in a hospital due to events 01Apr2021. Patient was discharged from emergency room. Pleaded with emergency room to give patient an epi pen to stop the side effects from occurring to get back to normal life and not deal with problem. Emergency room refused to give patient the epi pen, saying the epi pen would give the caller high blood pressure. Patient does not have high blood pressure. Patient thought that would be better than the reactions he was having. Patient stated that gave him a steroid. Patient was hoping there was an anecdote to stop the side effects to not continue going through this problem. Shot was not designed for where it was put, guess have to deal with unless answers. Patient asked what are the long term effects to the brain at end of blood stream? Have any idea? Nobody has answered. Vaccine should have been aborted, not injected into blood stream. Patient underwent EKG (Electrocardiography) in emergency room on 01Apr2021 and result was unknown. Patients second dose was scheduled for 27Apr2021, 41 days after first dose Pfizer, not 21 days. The seriousness for all the events was unspecified. The outcome of event paramedic gave vaccine and hit an artery was unknown and for other events was not resolved. No follow-up attempts are needed. No further information is expected.

01/27/2021 Presenting Problem/History of Present Illness/Reason for Admission Shortness of breath [R06.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course Is a 63-year-old male with type 2 diabetes obesity BMI 33 presents with shortness of breath secondary to COVID-19 pneumonia he received plasma remdesivir and 8 of his 10 days of dexamethasone is being discharged home on oxygen therapy he will finish out his dexamethasone at home follow-up with primary care provider for diabetes optimization given he has an elevated hemoglobin A1c

has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating; he is so tired; hard time breathing from gas/ had a hard time breathing last night; hives on his face on both sides of his cheeks; disturbance on his throat; felt like something was blocking his throat; This is the spontaneous report from a contactable consumer (patient wife). A 63-year-old male (patient) received BNT162B2 (lot number: EW0158) first dose on 14Apr2021 16 15 PM on left arm at single dose for COVID-19 immunisation. Medical history included allergic to milk and beef, gives him hives on his face. Concomitant medications included nasal spray (he doesn't take any other medication). No Prior Vaccinations (within 4 weeks). Consumer asked if her husband can take benadryl before the vaccine. Consumer stated her husband has no known allergies to medications. Caller stated that her husband had the first dose of the Pfizer covid 19 vaccine on 14Apr2021 at about 4:00 pm. Caller stated he ate dinner and then around 8;00 or 8:30 he felt like a disturbance on his throat. Caller stated he could swallow but felt like something was blocking his throat. Caller stated that 1/2 hour later it went away. Caller reported the next day (15Apr2021) he had hives on his face on both sides of his cheeks. He is so tired. Caller stated her husband has reflux, gas and bloating. Hard time breathing from gas. Caller stated her husband had a hard time breathing from gas last night (20Apr2021). Gas and acid reflux is worse on 20Apr2021. Vaccine Administered at Military Facility was no. No event require a visit to: Emergency Room or physician office. The outcome of event disturbance on his throat was recovered on 14Apr2021, hives on his face on both sides of his cheeks recovered on 15Apr2021, gas and acid reflux is worse recovered on 21Apr2021, hard time breathing from gas/ had a hard time breathing last night was recovered on 21Apr2021. The outcome of other event was unknown. No follow-up attempts are needed. No further information is expected.

You gave me shingles thanks alot for the warning. Severe muscle pain entire upper body. Rash from outbreak. Inability to sleep due to not being able to rest for 5 days. Hard to breathe. Worst 5 days ever for a totally healthy person.

Client complained of dizziness, little shortness of breath shortly after receiving his 2nd Pfizer vaccine. BP=100/60, 98%, 89 RR. Complain of pain in left hand rating it as 5/10 d/t gout. States that he stopped drinking 5 days ago (ten beers a day).

He got his vaccine, immediately had dizziness. Within 30 minutes could not move real good due to the Parkinson's. He got more confused, more dizzy, and worsening of his Parkinson's. He was very thirsty and drank a lot of water (4 liters of bottled water). He was then urinating and sweating a lot as a way of his body trying to get rid of something in his body. He was urinating more than he normally does. He started getting harder for him to breath. He noticed he had a bad taste in his mouth similar to when he had the COVID virus. He got a horrible splitting headache/migraine type that kept coming and going. He still has the taste in his mouth, and it affected the taste of food. These were all symptoms similar to when he had COVID. The headache was worse than when he had the virus. No appetite still, but still continuing to drink the water and not urinating like you did the first day and a half. He is not having to drink as much as he did before and not feeling like he was dehydrating. Does have the soreness from the vaccine or any rashes. He did have chills and low grade fever of about 100-101, which have resolved. He also had a sore throat which he still has. He had a very bad case of the COVID virus 3/1/21, which lasted for a week or two. He still has some residual symptoms from the virus with balancing/dizziness or worsening of his Parkinson's disease. His neurologist told him that he would recover from the cognitive effects from the COVID with his Parkinson's, but his motor skills may not return.

First dose received on 4/18/2021, second dose received 5/9/2021. Admitted to Hospital on 5/21/2021 with large pulmonary embolus and bilateral DVT. Patient became short of breath 3 days prior to admission, and the day of admission developed left sided pleural pain. Physical exam revealed a friction rub in left posterior chest. Patient was initially heparinized, then switched to oral apixaban bid and is being followed up as an outpatient. As of this day 5/31/2021 patient is asymptomatic at rest but still has dyspnea on exertion.

Shortness of Breath, cough, no taste, symptoms started Sunday afternoon, had send out covid on Monday was neg, (rapid was positive) pt has had both covid shots ? Nausea ? Fever ? Fatigue ? Headache ? Diarrhea Patient is on Rituximab and received doses on 5/12 and 5/29. which was 5 weeks after finishing vaccine.

Asthma is getting worse/ gasping/ short of breath; This is a spontaneous report received from two contactable consumers (one of them was the patient and the other was the patient's wife). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), intramuscular in left arm on 09Mar2021 15:00 (at the age of 63-year-old) as 1st dose, single for COVID-19 immunization. Vaccine was not administered at military facility. The patient's medical history included diabetes from two years before the present report (2019), weakness in legs from three and half years before the present report (2017) and asthma from 2005 and ongoing (patient mentioned he had been sick with asthma for 16 years (2005), it was work related). No family history was provided. The patient's concomitant medications included prednisone 10 mg, oral from unspecified date in 2005 at 20 mg and ongoing, daily (reported as two daily), benralizumab (FASENRA, lot number mm0071 and expiration date Mar2022) 30 mg/ml injection, parenteral from unspecified date at 30 mg cyclic (reported as one ml by injection once every two months), both for asthma. No prior vaccinations within 4 weeks as well as no additional vaccines on same date of the Pfizer vaccine were administered. Patient stated that the literature stated not to take any other injections of any kind. He was on FASENRA for his severe asthma. It is a blocker of eosinophils. He was due to have it once every 2 months, but it was on the same time as the Pfizer shot so he didn't take it. His asthma was getting worse. He was gasping and short of breath. He had been on prednisone for 16 years from the time of this report (2005). He was on 20 mg he could boost to 35 mg so he could deal with his asthma (and not get the FASENRA shot). He was 15 days overdue for his FASENRA shot. He needed to wait 3 weeks after his first dose to get the 2nd dose and wait more week to get his FASENRA shot. Patient asked if he could get up on prednisone and why it did state not to take any injections during and after the vaccine. At this point the vaccine was more important. He also asked what the reason was and if it was stressing on the injections. That was his main conflict. Patient also asked if having not had side effects did it mean that the vaccine had not work. As per response provided it was stated that there was no information in the Pfizer-BioNtech COVID-19 vaccine prescribing information about a potential interaction or administration with FASENRA. Patient read not to take any injections because it might interfere with the vaccine. However, every two months he gets a FASENRA injection for severe asthma. He had it in his refrigerator for someone to administer to him at his house because he was afraid to go to the doctor or the hospital because of COVID. Reported his asthma started getting worse last week (Mar2021), he was unsure what day. He added he was on prednisone 20 mg and was still gasping for breath when he had to go up stairs. He added they also said there was concern about prednisone. He stated he might be able to stabilize if he went up on the prednisone. He added he was supposed to take his FASENRA injection about the same time as the vaccine and at the time of this report he was overdue for the injection. He added maybe he should just take it in a different arm. He was scheduled to receive the next dose of the vaccine on 30Mar2021. He added the FASENRA blocks eosinophils and he thought not having the FASENRA was contributing to his problem. He was asking what the prednisone did in relation to the vaccine because they asked him to wait longer and if he could take his FASENRA injection. He also asked if there were any medications he was not supposed to take with the vaccine. The event did not require emergency room or physician office visit. The outcome of the event was not resolved. No follow-up attempts are needed. No further information is expected.

Experienced lightheadness about 1/2 hour after shot. Then days later, symptoms come and go. Naseua and shortness of breath continue for months. Bloodwork done, EKG showed irregular rythm, referred to cardiologist. Feeling better at time of visit, all additional tests ok. Weeks of extreme fatigue and lightheadness occur for periords lasting 6-24 hours at average. Any major activity would cause debilitating weakeness the next day. Felt so badly one night, thought he was dying, didn't go to ER (was affraid of expense). Another day again we drove to ER, but started feeling better during wait time and decided not to stay. Was going to return if not feeling good, but felt better for 3 days, longest period to date.

Shortness of breath, gradually progressed over two weeks time to become more pronounced. Doctor visit on 6-5-21 and lab tests showed elevated D-Dimer results, indicating presence of a blood clot, where CT scan showed presence of "extensive" clotting, primarily in lower lobes. Was prescribed blood thinner medication (Xarelto). Remained in E.D. overnight under observation. Results over the past four days are that breathing is getting better.

Patient stopped breathing at 6:15pm on 04/22/2021. Fire dept was called. He went into cardiac arrest and they took him to ICU. He died on 04/26/2021 in ICU.

After being fully vaccinated I contracted the COVID virus with in two months. My symptoms was fatigue, nausea, shortness of breathe, and light headedness.

Patient is a 63 y.o. male with PMH significant for COPD, PE, DVT, left upper lobe cavitary lesion felt to be aspergilloma as well as chronic biventricular CHF and coronary artery disease who presented to the emergency department with increasing shortness of breath and cough over the last 7 days. The patient states that he had run out of his albuterol inhaler about 7 days ago. He states that the sputum is clear. He reports wheezing as well as chronic lower extremity edema. The patient states that he has received 2nd dose of Pfizer vaccine about 2 weeks ago. In the emergency department, he initially 3 L nasal cannula. COVID-19 PCR returned positive, NT proBNP was elevated at 2242. Patient underwent chest x-ray revealed a stable left upper lobe mass, with some small nodules and fibrosis noted at the right base

Feeling sick; Run a temperature; He still has been running a temperature of 102.3; Real bad headache; Little difficulty in breathing; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EN6198), via an unspecified route of administration on 23Feb2021 12:00, unknown dose, as single dose for covid-19 immunization. The patient's medical history included congestive heart failure, diabetes mellitus and peripheral neuropathy. Concomitant medications included gabapentin taken for an unspecified indication, carvedilol (COREG) taken for an unspecified indication. Patient takes short and long-acting insulin for diabetes mellitus. On an unknown date, the patient experienced sickness, run a temperature; he has been running a temperature of 102.3, real bad headache, little difficulty in breathing and, fatigue. The patient underwent lab tests and procedures which included body temperature: 102.3. The reporter stated he had 15 to 20 percent ejection fraction and he takes insulin short acting and long acting, but there is no further information. Therapeutic measures were taken as a result of the events with Tylenol. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Day after 2nd shot I had most all my covid symptoms (heavy fatigue, brain fog, bad constipation, stomach pain. severe joint pain that moves all over my body. 5 plus nights get chills and bad head fever. My breathing progressed worse as time went on and was hospitalized 7/1/21 with covid pneumonia, they worked hard and got it controlled fast and was released late 7/2/21. Now I am working from home on oxygen and quarantined.

My adverse was more a lung Covid-19. My doctor called it Covid-19 induced asthma. I had low oxygen levels. I had tightness in my chest and hard to breath.

discomfort in left shoulder blade area. pain in taking breath in back. tiredness, sweats, and discomfort in both kidney areas.

Shortness of breath is primary complaint, BP = 219/91 on arrival. Cardiology consult. Patient admitted to critical care unit, pacemaker placed. Patient to go home with furosemide, spironolactone, adjustments in antihypertensive meds with follow up with cardiology.

During check in, Pt stated that he had hives that started 1 week after his first Covid vaccine.Pt received 2nd Pfizer Covid 19 vaccine. During the post vaccine observation time, pt was slumped over in the chair and moaning. 0858 This nurse sat beside pt. Asked questions, pt did not answer. Attempted to assist pt to a sitting position and pt slid and was assisted to the floor. Pt lips were pink and pt was rolling on the floor and not answering direct questions. 0900 911 was called. 0902 Pt had gasping breaths. EpiPen administered in L thigh. Breathing improved.0908 Pt calm, pulse ox placed HR 92, sats 99%. 0910 Pt began rolling around again. 0913 Paramedics arrived.

He had Covid 19 on Thanksgiving 2020 and recovered fully. Even though he now had natural antibodies, his Doctor convinced him that he needed the so called Covid 19 vaccine "mRNA gene therapy". On 04/29/2021, he was injected with the so called vaccine and that was the beginning of the end. On 05/10/2021, he was admitted to the Hospital with irregular heartbeat and trouble breathing. The Hospital could not get him stabilized so they transported him to another Hospital. He was there a couple of weeks or so and was now having issues with his kidneys and liver. It appeared the spike proteins had started to battle the rest of his viable organs. The hospital had to transport him to a nursing home facility because his number of days in the hospital per insurance had run out. Then on the evening of 06/13 or 14/ 2021, he became violently ill. He was taken to hospital again and was subsequently transferred back to another Hospital. The Spike proteins had now gone into overdrive attacking all his major organs. His liver, kidneys, lungs and heart were being attacked by the spike proteins created by this deadly vaccine. He was put on 24 hour dialysis and then had to be put on a ventilator. He died 06/24/2021.

shortness of breath for two days, came in to the er and found to have bilateral pulmonary embolus, heparin gtt and hospitalization

The first symptoms were a headache and then breathing problems. I was having more intense headaches that they were becoming more frequent. About 4 weeks ago I had a 10-day period of headaches, but I needed to seek medical attention. The doctor diagnosed me with cluster headaches. I also had elevated blood pressure which I had never had an issue with before. The doctor also wants me to have an MRI schedule to make sure there are no underlying physical issues causing the headaches. The medication i was prescribed is helping the pain but I am still getting the headaches.

Headache; I got small fever like 99.9; Muscle pain; Feeling unwell; Difficult breathing just a little bit just like a cough a little small cough; Difficult breathing just a little bit just like a cough a little small cough; Dizziness; Cold; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure, and cholesterol. Concomitant medications included diabetes medication, medications for high blood pressure and for cholesterol. The patient stated that he got the Pfizer vaccine on Christmas eve that would be the 24th and today (30Dec2020) he was getting just small things like headache, fever (small fever like 99.9), muscle pain, feeling unwell, difficult breathing just a little bit just like a cough a little small cough, dizziness, and probably just a cold. There was no injection swelling, fast heartbeat, and rash. He doesn't know if he should go get tested for COVID or not because he just took the shot. The patient stated that he got to get the next dose of the vaccine on the 14th of January. The outcome of the events was unknown.

Pleuritic chest pain in left parasternal area upon inhalation starting 1/12/2021 at ;7:30 am. I went to ER. Given chest x-ray, EKG and blood. All negative; to have cardiac treadmill morning of 1/13/2021. Pelvic pain started 19:00 1/12/2021 when I returned from ER.

Patient was was brought to the ED from facility which he received the vaccine via ambulance with BiPAP, hypoxia, and one dose of Epi of 0.3 mg. He then required intubation, and had struggled with hypoxia, even on increasing PEEP. CODE BLUE called in the ED for PEA. He was medicated for such (please see the code run sheet for details), and he came in and out of the code 5 times. After 95 minutes, with the wife at the bedside, and family conference by phone, the code was called, and he was pronounced at 18:20. He received in total 8 me of Epi, 3 shots of Atropine, 3 amps bicarb. He got lasix 40 mg, lovenox 60 mg subcutaneous once. He had a CVC into the right internal jugular, and levophed was started, then Epinephrine drip was started. Prior to the code he got steroids (solumedrol 125 mg, then later decadron 6 mg iv), benadryl iv, antibiotics (ceftraixone / zithromax), and lasix 40 mg. All this time while in the ED, the Rt was at the bedside, and lots of secretions from the lungs were aspirated, bloody color. Code was the result of PEA secondary to hypoxia (</= 85%), despite being on the vent, with PEEP 12, FiO2 of 100%, with acidosis. After 95 minutes of active resuscitation, the patient was found not responsive to painful stimuli. There was no palpable pulse. No spontaneous respirations. No heart or breath sounds by auscultation. Absence of pupillary light reflex.

Note Text: Resident oxygen was going down to 74% during change of shift 3-11, oxygen initiated 3liters via nasal canula per standing order want up to 84-86% NP notified, ordered Prednisone 20mg stat, Rocephin 1gram IM stat administered, Per NP statement if pt's condition worsening sent him to ER, continue monitoring pt and his oxygen going to 82% increasing distress. Notified Nurses supervisor, 911 was called pt left building at 1819 to Hospital alert oriented. Vs bp. 165/60, temp. 98.3,m pulse 109, res 22, 02. 82%. Resident father notified.

Pt received first dose of Pfizer COVID-19 vaccine on 2/6/2021. Pt subsequently developed symptoms of COVID-19 and presented to the ER on 2/15/2021. Chief complaint was cough, fever, and shortness of breath. Reports that he had a negative nasal swab as recently as 2 weeks ago. Reported that symptoms of cough, sob, and weakness started 3 days prior to presenting at ER (2/12/2021). Chest Xray had features of bilateral pneumonia. Pt is still currently inpatient at our hospital, receiving treatment for COVID-19, including dexamethason and remdesivir. He is currently receiving 3L of supplemental O2 via NC.

Shortness of breath and, pressure and or tightness in chest. Symptoms began to subside 1:15 after injection

I initially felt unease then I felt swelling in my throat with dry mouth and some difficulty swallowing

20 minutes after receiving Pfizer dose, he had metallic taste in mouth, felt dizzy. Vitals 111/58 HR 46. pulse ox 96% on RA.Patient given Benadryl. Metallic taste improved and dizziness improved. He stated at this point that it felt like his throat was swelling so epi was administered. He went to the ER as directed but not by ambulance. He was treated there rom 6:15 to 9:15. Received monitoring and decadron IV.

Symptoms: Patient states that he has HX of COPD and has noted an increase in SOB on Sunday. He states he is taking his ProAIr inhaler every hour and it helps for the hour, but after that his breathing gets worse. Patient states he gets SOB with lying down and walking. Patient was speaking in full sentences and states it was because he just took his inhaler medication. Patient states he is positive for chills onset Sunday. Patient did have his first dose of COVID vaccine on Thursday. Denies difficulty breathing on Thursday, and per patient could have started Saturday night. DIAGNOSIS at time of disposition: 1. Chronic obstructive pulmonary disease with (acute) exacerbation (HCC) Patient is a 64-year-old gentleman with history of chronic obstructive pulmonary disease, on p.r.n. albuterol at home as well as nightly Spiriva, coming to the emergency department for evaluation of worsening shortness of breath over the last 3 days with associated tightness with his breathing. On arrival to the emergency department, patient is sitting forward, tachypneic, prolonged expiratory phase with diffuse expiratory wheezing. He is saturating low 90s on room air. He is placed on 2 L nasal cannula for comfort. He received 2 DuoNeb treatments with EMS as well as Solu-Medrol. I am going to treated with a continuous nebulizer treatment and obtained laboratory workup as well as chest x-ray. Vital sign show tachycardia which is likely from his albuterol treatment, he is mildly tachypneic, otherwise stable. Patient's laboratory workup is reassuring, troponin is negative. Chest x-ray does not show any consolidation. Patient does have some improvement in his symptoms after his continuous nebulizer treatment. His VBG is repeated after treatment and shows that his pCO2 is going down however he is still slightly acidotic with the pH of 7.28. Patient reports that he still tight in his chest, improved however uncomfortable going home. He is still significantly wheezing on my exam, given this I did discuss this case with emergency department observation who agreed to accept for admission. COVID testing is negative. Patient is admitted in stable condition. Pulmonary: Comments: Patient is sitting forward in the stretcher, he is tachypneic, prolonged expiratory phase with expiratory wheezing in all lung fields.

Pt presented to the ER on 1/4 2021 with worsening sob, found to have acute ST elevation MI and new rapid atrial fib with RVR. He tested positive for covid 19 requiring new oxygen and received his first pfizer vaccine on 12/31. He was acutely transferred to rochester general hospital. He progressed to multiorgan failure, sepsis, mrsa bacteremia and died on 1/14/2021

SORE LEFT ARM AND NECK, LETHARGIC, LIGHT HEADNESS, HEADACHE, SOME SOB TX- SLEPT/ REST MORE AND DRANK EXTRA FLUIDS

Extreme muscle weakness beginning 48 hours after second Pfizer shot. Confusion and slurring of some words. Difficulty walking. Still experiencing mild symptoms almost one week after the second shot.

Hard to swallow, but I can swallow liquids. Throat is swollen. Dizziness & chills. Not going to the ER unless it gets worse.

Anaphylaxis, dizziness, flush, itching, nausea, headache, heart racing, difficulty breathing. Gave me EpiPen. Was in ER for 4 hours after. Took antihistamine every 6 hours for 3 days.

COVID-19 Infection Narrative: Patient received dose of Pfizer COVID-19 vaccine on 2/23/21. On 3/5/21 the patient presented to the emergency department with fever of 102.4 F, chest pain, dyspnea on exertion, non-productive cough and diarrhea. Pt was tested and found to be positive for COVID-19 infection. Patient initiated on remdesivir and dexamethasone for treatment of COVID. Remdesivir discontinued due to new onset acute kidney injury. Patient completed course of dexamethasone. Patient discharged home on 3/9/21. Has not received second dose of vaccine.

Patient with severe COPD and respiratory failure on home O2, currently undergoing evaluation for potential lung transplantation. Patient reports feeling "fine" and got his vaccine 4/1. On 4/2 in the evening he developed feeling of malaise and fatigue, fever, and by 4/3 he noted cough productive of brown sputum, and dyspnea which became progressively severe. Presented then to the ED 4/3 where he appeared to be in respiratory distress and was treated with BiPAP, albuterol/atrovent nebs, solumedrol, then prednisone, antibiotics (levaquin in ED, then doxycycline after admission), hypertonic saline . Remains admitted, still on higher O2 requirements than baseline.

Approximately 1 hour after injection, experienced strong facial numbness which lasted about an hour. Approximately 9 hours after injection, experienced very weak and shallow-breathing.

SEVERE CHEST PAIN emanating from solar plexus area. Head/Neck/Body aches, chills/fever, nausea, loss of appetite, difficult to breath, sleep and urinate. Dr. told me I have a virus (unknown). COVID-19 Rapid Test- None Detected. LAB RESULTS - 11 anomalies; P02 Venous-23 low, 02 Saturation-43% low, RBC-3.77 low, Hemoglobin-11.7 low, Hemocrit-39.5% low, MPV-7.3 low, Potassium-3.3 low, CK-293 high, Alkaline Phosphate-29 low, Amylase-108 high, Leukocyte Esterase- Trace. Script for 2 days med for nausea and released after 4hours. Symptoms lasted 8 days.

Dizziness, difficulty breathing for 3 days, fever in excess of 101.6 for 2 days, loss of taste, loss of appetite, severe fatigue, body aches especially in neck and chest,

Pt received Pfizer vaccine 1st dose on 3/12/21. Pt became positive with COVID on 3/31/2021. Pt admitted to the hospital for SOB on 4/10/21

Patient received first dose of pfizer (lot # ER8729 )at 11:17AM. Individual complained of sick feeling. EMT found no abnormalities, EMT assessment: BP-110/60, RR-16, HR-66, A&Ox4, PERRLA, skin warm and dry, lung sounds clear to auscultate. EMT notified RN of Individual complaints. When RN first arrived on scene individual was sitting in chair erect. Client appeared sweaty having labored breathing. Client state "I am feeling tightness on my chest. EMT took individuals vitals (BP 110/80, HR 90, RR 16, SPO2 98). Individual was found to have a history of high blood pressure and diabetes. Currently taking metformin and medication for high blood pressure but denies taking the diabetes medication this morning. Additionally individual was alert and oriented times three and had clear lung fields as assessed by the EMT. Despite no change in vitals, 911 was called at 11:35 by lead ancillary. During which time the individual stated "I'm starting to feel drowsy and sleepy." Paramedics arrived on scene at 11:40 at which time the EMT and RN transferred care. The individual refused ambulance transportation and signed waiver. Individual was asked if symptoms had improved or if they were the same and he stated "I feel the same." Upon giving this answer, the signed the AMA, the last assessment: client breath sounds were assessed to be clear to auscultate, speaking in full sentences without shortness of breath, was A&OX4, skin was warm and dry and not showing signs of anaphylaxis. At 11:40AM and upon completion of the last assessment, the individual departed the facility without any assistance with a steady gait.

4/5/21 Patient presented to ED w/fever, weakness, cough and SOB. Initial temp was 103 and RA pulse ox 87%. Signs of AKI with cr up from baseline of 0.9 to 1.49 and he was hyponatremic (Na 130). Pt was admitted on O2 per NC, IVF, Decadron and Remdesivir. He completed a 5 day course of Remdesivir. AKI and hyponatremia resolved. he was not able to be weaned off oxygen. H was discharged on 4/13 on oxygen 2L per NC and Decadron to complete a 10 day course.

This is a pleasant 64yo male that presents to Hospital with acute SOB. He states that yesterday morning he received his covid-19 vaccine and then went home. Later in the afternoon he developed acute SOB, not made worse by exertion or lying down. He has chronic COPD and checks his pulse ox multiple times per day. He typically runs 85-92% and states that he was running around 87%. Due to his SOB he sought medical care and was found to be hypoxic with an O2 saturation of 78% in the ER. He had a CTA of the chest which showed a chronic left lobe PE and an acute PE to the left subsegmental branch of the inferior lingula artery, small bilateral pleural effusions and cardiomegaly. There was no evidence of right heart strain on the CT readout. His first two troponins are WNL. He admits to being sedentary at home over the last year since he lost his job. He was also found to be in a-fib with RVR and intermittent a-flutter, both of which are new per patient report. He has been started on Cardizem and Heparin drips. Currently, he is up ad lib and comfortable. He denies overt shortness of breath and is able to carry on a full conversation. He denies chest pain, abdominal pain, m/s pain, bowel/bladder issues, n/v/d or diaphoresis. He is alert and oriented. He has a PMH of copd, chroinc hypoxia, tobacco use, ble pitting edema, htn, and hld.

1- Mild cough became severe associated with shortness of breath starting from second day. Since the symptoms were progressively worsening, on doctors advice took one course of Z Pack (Azythromycin) starting from Wednesday04/14. 2- Still having mild cough. 3- Having dry upper respiratory passages leading to choking sporadically (once or twice on some days day). 4- Vision getting poor noticeable with watery eyes, started to feel 3 to 4 days after getting first doze COVID19 vaccination. Consulted an eye specialist on 04/24, who believes the vision issue is due to cataract getting progressively worse. As far as I know, cataract does not gets worse over period of 3 to 4 days, so there is likely hood of some adverse effect of the COVID vaccination.

Per family, patient received 2nd vaccination and began experiencing swelling and shortness of breath the following day. This progressed over the course of 2 weeks until this today when he suffered a cardiopulmonary arrest and could not be resuscitated. Death resulted on April 24th 2021.

Strong chest pain that lasted several days. One day was so intense I had to sleep upright. I would get winded walking up a flight of stairs. Normally I run 3-4 miles for workouts. I had pericarditis in my 30s and it felt very similar.

I was sick for 8 days, ran a fever, had breathing problems at the end and than it cleared up. Far cry form having few symptom for a few days.

Pt was admitted to the hospital 4/26 with fatigue and dyspnea and tested positive for COVID (non ICU)

Difficulty breathing that started after the first shot and worsened after the second shot. I thought it might be asthma at first, but I have never had difficulty breathing before and an inhaler made no difference.

Dose #1 EN 6199 3/10/2021 Dose #2 ER 8132 3/31/2021 Acute PE/DVT on 4/6/2021 Hospitalized with leg swelling shortness of breath Diagnosed with submassive PE, right lower extremity extensive DVT Anticoagulation started subsequently discharged home

Loss of Breath after 5 days after both Vaccines Urgent Care concerned about Blood Clot Hospitalize 3 days - New diagnosis - Congestive Heart Failure

acutely worsening shortness of breath requiring up to 90% FiO2 on high flow nasal cannula. Was treated for possible pneumonia. was able to come off of oxygen within two days.

felt pain at injection site; dry mouth; feeling cold; dry eyes; rapid pulse; his breathing changed'; states it was hard to breathe; felt like he had fever; This is a spontaneous report from a contactable consumer (patient). This 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 04Apr2021 for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient stated after injection, felt pain at injection site and felt like he had fever; fever lasted 2 days (as reported). Patient also added immediately after receiving the shot, he had a 'rapid pulse and his breathing changed' on 04Apr2021; stated it was hard to breathe. Patient stated he calmed himself and he was ok. Patient reported 2 weeks later after the first dose, he reported shortness of breath, dry mouth, feeling cold and dry eyes (unclear timing/onset). Patient stated these were ongoing currently. Patient was asking if these could be side effects. Patient also reported that he cannot take medications; he had allergies to medication (did not specify). Patient asked should he delay second dose given he had ongoing side effects from the first dose. The outcome of events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

On 04/22/2021, a patient was determined to have pericarditis, possibly secondary to COVID-19 vaccination. The patient received his first COVID-19 vaccination (Pfizer) on 2/27/2021. The patient reported feeling poorly and presented to ER on 03/02/2021 with chest pain and dyspnea. He states the chest pain he is experienced this week is similar to the 2 episodes of chest pain he had after each of the two-step Pfizer COVID vaccination that he received in February 02/27/2021 and March 03/15/2021. He underwent a stress test on 03/11/2021 which did not show any reversible perfusion defects. Of note, the patient had COVID-19 back in October 2020 which manifested with night sweats, malaise for a few days and then cleared completely without any "long hauler" symptoms. The patient was treated with ibuprofen and colchicine. I did not find any evidence suggesting a relationship between pericarditis and covid-19 vaccination. In clinical trials, pericarditis was not statistically significantly different between treatment arms. Other potential causes of pericarditis include atrial fibrillation.

My husband who is 64 years old, was a previously in good health. Only history was mild cardiomyopathy diagnosed 12 years ago. And elevated blood pressure, which was normal with medications. He was very active, maintained a demanding full time job and was a great husband of 2 children. He received his 2nd dose of Pfizer on approximately 4/1/21. He didn?t complain of any side effect. However, on the morning of 4/27/21 he woke me up saying that he could not breath. We started driving to the hospital, however he got worse and we stopped at the fire station. They gave his oxygen and rushed him to the hospital. We came to hospital and when the fire truck was pulling in, I was told that my husband went into pulseless electrical activity. CPR was started and after approximately 5 minutes he regained pulse. He was taken to the ICU and therapeutic hypothetic protocol was completed. Since then, he is still requiring mechanical ventilation. He opens his eyes spontaneously, at times appears to obey small commands and is bedridden.

1st dose in series on 03-18-2021; 2nd dose in series on 04-08-2021 2 days after 2nd dose, he developed severe pain in both legs. He was taken to the hospital where clots were diagnosed in both legs and groin area. A previously undiagnosed lung nodule was found and he was given a cancer diagnosis. He was discharged home on apixaban (Eliquis) and comfort measures 2 days after admission. Over the following weeks, he had a permanent lung drain placed. He died on May 5th or 6th at home. No autopsy performed.

SOB w/exertion, feels foggy in the head, nausea, bodyaches, joint pain, dry cough & severe intermittent L side "ache" (feels like a pulled muscle) Pneumonia due to COVID-19 virus - carvediloL (COREG) 3.125 mg tablet; Take 1 tablet (3.125 mg total) by mouth 2 (two) times a day - HYDROcodone-acetaminophen (NORCO) 5-325 mg per tablet; Take 1 tablet by mouth 2 (two) times a day as needed for moderate pain or severe pain

pt developed generalized papular/drug rush 2 days after vaccine on all extremities and trunk. this eventually started to resolve after about 3 weeks and a course of prednisone. on 5/6 he developed shortness of breath/chest pressure worse on exertion. he was hospitalized with a negative cardiac workup (telemetry, trops, nuclear stress test) negative chest XR and negative CTA chest for PE. VS remained stable throughout. some improvement now with prednisone. unclear if related to his vaccine but pt feels it was.

fainted; fell and hit his head; fell and hit his head; felt lightheaded/Dizziness; blood clots in his lungs; he has a spot on his lung that they are monitoring; hypoacusis and has a new hearing aid; This is a spontaneous report from a contactable consumer (patient's wife). A 64-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), via an unspecified route of administration, administered in Arm Left on 02Apr2021 (at the age of 64 years old) (Batch/Lot Number: ER8733) as 1st SINGLE DOSE for covid-19 immunisation. Medical history included severe sleep apnea from 18Mar2021 (received a machine not long after), gout (diagnosed about four years ago) , ex-tobacco user from an unknown date to an unknown date (two pack a day smoker over thirty years). Concomitant medication included colchicine (COLCHICINE) 0.6 mg, 1x/day taken for gout, start date was not reported to Apr2021. The patient experienced blood clots in his lungs (hospitalization, medically significant) on 02Apr2021 (also reported as 02May2021). , fainted, fell and hit his head, felt lightheaded/dizziness on 02Apr2021, The patient was hospitalized from 2Apr2021 to 4Apr202. It was reported the patient experienced hypoacusis and has a new hearing aid on an unspecified date. Caller says her husband has new hearing aids, which is why he is not doing the report himself. Patient has a spot on his lung that they are monitoring on an unspecified date. The patient underwent lab tests and procedures which included blood test: results unavailable on an unspecified date , 'they did a couple tests' (details not provided) results unavailable on 02Apr2021, urine analysis: results unavailable on an unspecified date. Therapeutic measures were taken as a result of blood clots in his lungs included Thrombectomy on 02Apr2021. The clinical course was reported as follows on April 2nd her husband received his first dose of the Pfizer COVID-19 vaccine. Approximately an hour later they went to the market and he felt lightheaded, so instead of getting out of the car they sat there 20 minutes. He started to get out again then halfway out the door he fainted and fell down on the ground. She says he was out for, 5-10 minutes, clarified to not even a minute. Since he hit his head she called an ambulance, and they took him to PRIVACY in PRIVACY. They did a couple tests and said since it was so soon after getting the vaccine that they did not think the vaccine had to do with his blood clots. Caller also stated he fainted because that was one of the side effects of the vaccine, but they were glad he got there since he had several blood clots in his lungs. On the same day (02Apr2021) he had a thrombectomy to remove the blood clots and put him on a blood thinner. Patient was admitted to the hospital April 2nd and was discharged April 4th. He is doing better, he is on a blood thinner now. She says there were a few doctors that had to weigh in on whether he should get the second dose, they decided it wouldn't affect it since the vaccine goes into his muscle. No other vaccinations on the same days as his Pfizer COVID-19 vaccinations or during the four weeks prior. Once they placed him on a blood thinner, they took him off Colchicine 0.6mg. He stopped taking Colchicine because they said the blood thinner doesn't work with that particular medication. It was also reported The patient is to schedule an appointment with a rheumatologist and a hematologist, they did blood work and a urine test and said he has a spot on his lung that they are monitoring. The clinical outcome of the event blood clots in his lungs was Recovered/Resolved with Sequel while the remaining events was unknown. The second dose bnt162b2 was administered on April 29th. LOT: ER8751, caller hopes that is a 5, the writing is very bad on there. The patient had no side effects from his second dose of the Pfizer COVID-19 vaccine.

shortness of breath which is been ongoing for the last several days. His symptoms have progressively worsened over that time. He was seen here in the ED 5 days ago and had a neb treatment for COPD, he had a positive D-dimer and negative CT angiogram of the chest for PE. He was discharged home on Azithromycin and prednisone for AECOPD. His symptoms unfortunately continued to worsen with increased cough and shortness of breath no fever, chills, sore throat, nausea, vomiting or diarrhea. He came back to the ED today for evaluation since he was feeling worse. Patient has a history of lung cancer on the right status post pneumonectomy in 2013. On initial eval in the ED he was noted to have bilateral rhonchi on the left greater than right and received neb treatments and Solu-Medrol 125 IV push. His symptoms did improve somewhat. ED staff checked a COVID 19, despite confirming his second Pfizer vaccine was received on 3/21/2021, and it came back positive. Procalcitonin was negative. He clearly has an exacerbation of his COPD but with the COVID 19 positivity, the ED staff was concerned with his comorbidities that his prognosis is poor in the face of progression of symptoms. I was contacted and agreed to admit him for Remdesivir therapy, supplemental O2, dexamethasone and supportive care.

ED Discharged 4/19/2021 (2 hours) Last attending ? Treatment team Cough with exposure to COVID-19 virus +1 more Patient presents with ? Fatigue HPI: Patient presents with a 3-day history of illness, started with a cough, generalized fatigue, some nauseousness and decreased energy. He is here today with wife, over the last 2 days has not really ate or drank much, only had 1 cup of chicken noodle soup, states he has not really ate or drink anything secondary to no appetite. Denies any diarrhea. Denies history of problems with his heart or lungs such as asthma COPD smoking heart failure or heart attack. Denies any new or different swelling in his lower extremities, denies hemoptysis. Patient had a COVID-19 test at pharmacy and was told the results may take 2 to 7 days. He has received one of his Covid vaccines but not the second, he was recently at an orthopedics appointment, otherwise denies any recent known exposures or other sick individuals to his knowledge. Wife was fully vaccinated for COVID-19. He does admit to feeling more short of breath. Patient is retired Clinical Support 4/23/2021 COVID-19 Dx Medication Infusion Reason for Visit Progress Notes (Registered Nurse) ? ? Encounter Date: 4/23/2021 ? ? Signed 12:30 pm: Patient arrived in clinic for MAB infusion, wheeled to the clinic on a wheelchair, reports generalized weakness and a cough, no SOB. VS acceptable . 12:52 pm - Commenced on MAB infusion 01:15 pm - Infusion ended successful with no adverse reactions. VS stable. Will observe for 1 hour before discharge. 02:15 pm - Patient stable post infusion. Given a pulse oximeter and shown how to use it, educated on when to seek help.Navigators to make home follow up calls.Discharged home. Instructions COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide ED Discharged 4/26/2021 (5 hours) DO Treatment team Bilateral pulmonary embolism (CMS/HCC) +6 more Patient presents with ? Shortness of Breath History of Present Illness: Patient is a 64-year-old male who presents for respiratory distress. Patient has recent history of Covid approximate 10 days ago who presents for shortness of breath. Patient says he woke up acutely short of breath with pain in the center of his chest. EMS arrived, they said patient was diaphoretic and they could not get a pulse ox. Patient's blood pressure was normotensive. Patient now continues to feel like he cannot breathe. Patient reports some mild pain in the center of his chest. Patient denies history of DVT or PE. Patient denies history of COPD or asthma but he is a former smoker. Patient said he was started to feel better from a Covid standpoint until this morning. Admission Discharged 4/26/2021 - 4/29/2021 (3 days) Last attending ? Treatment team Pulmonary embolism associated with COVID-19 (CMS/HCC) Principal problem Discharge Summary (Physician) ? ? Internal Medicine INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/29/2021 DOB: 10/28/1956 Admission Date: 4/26/2021 Length of stay: 3 Days Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Pulmonary embolism associated with COVID-19 (CMS/HCC) Yes Essential hypertension Yes Other hyperlipidemia Care Coordination Progress Note RN (Registered Nurse) COVID 19 MAB Infusion Navigator Post Infusion Graduation Infusion Date: 04/23/21 Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab

got cold, chilly, and freezing; diarrhea; throwing up; Fever; Sucking Breath, cant breathe and was out of air; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in the left arm on 30Apr2021 at 08:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing hypertension (diagnosed 20 years ago, in 2001), ongoing diabetes mellitus(diagnosed 10 years ago, in 2011), ongoing high cholesterol (diagnosed last year, in 2020), ongoing triptococcus, ongoing myocardial infarction with stent placement (reported as on 16Sep), ongoing gastrooesophageal reflux disease ( GERD) (diagnosed 10 years ago, in 2011). Concomitant medications included valsartan for hypertension, start and stop date were not reported; glipizide (GLIPIZIDE XL) for diabetes mellitus, start and stop date were not reported; atorvastatin for blood cholesterol increased, start and stop date were not reported; ticagrelor (BRILINTA) for an unspecified indication, start and stop date were not reported; carvedilol for an unspecified indication, start and stop date were not reported; omeprazole for gastrooesophageal reflux disease, start and stop date were not reported; fluconazole for triptococcus, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on an unknown date in the beginning of Apr2021 in the right arm (Lot Number: unknown) for COVID-19 immunisation. The patient reported in was about four weeks between the two shots. On 30Apr2021, the patient experienced sucking breath, cant breathe and was out of air, got cold, chilly, and freezing, diarrhea, throwing up, and fever; all events for which the patient was hospitalized. The patient was hospitalized from 01May2021 to 06May2021. Clinical course: Two Fridays ago (on 30Apr2021), patient got second shot. He stated that he came home, he eventually went to the store, got back from the store. He stated that he walked the 20 steps from his car to his house and was sucking breath. He states he couldn't breathe and was out of air. He got really cold, chilly, and freezing. Had to lay on couch with comforter on. Started having diarrhea and throwing up. He had a fever. He states that he ended up in intensive care for 6 days. Patient stated he is on an inhaler but does not seem to work. He stated his breathing problem has improved, they had him on so many antibiotics, but it's still there. Caller did not provide products names regarding the antibiotics he was on. He states that when he had the chills his teeth were clattering. He stated that he still gets a little chilly but it is pretty much gone. He stated that the diarrhea has not stopped it is still real bad and he is having like black water coming out. He stated that the vomiting stopped on 09May2021. He stated that he has been unable to eat because he been so sick. He stated that he went to the hospital at about 9:30 am Saturday morning, on 01May2021. He said they were going to put him on a ventilator or a breathing tube, but he did not want that. He was on oxygen and 3 IV antibiotics at one time. He says on 06May2021 he left hospital. He stated that he told at least 20 people not to get their shot and they agree now. He states that there is something wrong with the vaccine somewhere. The patient recovered from the event, throwing up on 09May2021. The patient was recovering for the events, experienced sucking breath, cant breathe, and cold and chills. The patient had not recovered from the event, diarrhea. Outcome of the event, fever was unknown. Information about lot/batch number has been requested.

out-of breath; 1-1/2 days after injection began as rash on lower middle back-(looked like a picture of measles)-spread throughout entire body except for face/head over the next few days; moved into lungs-pressure; burning; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 14:30 (Batch/Lot Number: ER8731) as 2nd dose, single (at the age of 64 years) for covid-19 immunisation. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing. The patient has not had Covid-19 prior to vaccination. The patient has no known allergies. Concomitant medications included lisinopril; diltiazem; and cholestyramine, all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose, an unspecified route of administration, administered in Arm Right on 31Mar2021 11:30 (Batch/Lot Number: ER8737) for covid-19 immunization. On 23Apr2021 at 7:30, 1-1/2 days after injection began as rash on lower middle back-(looked like a picture of measles)-spread throughout entire body except for face/head over the next few days Despite treatment/testing at hospital has moved into lungs-pressure, burning and out of breath. It was reported that the events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization for 1 day. The had testing and breathing med as treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test (covid): negative on 07May2021 via nasal swab. The outcome of the events was recovering.

Body rash on foot 4/3/2021 Edema/fluid in lungs 5/7/2021 Kidney Failure w dialysis 5/16/2021 CRRT & ECMO 5/28/2021

Shortness of Breath for few days after vaccine #1; after vaccine #2 shortness of breath increased along 10 day period, so I contacted PCP. Clinical exam, chest xray, blood work resulted D-Dimer level increase, so CT scan ordered. Result was lungs full of PE. Placed on Eliquis and referred to hematologist. Hematologist ordered deeper dive in blood work as well as echocardiogram, which displayed a widening in aortic root and ascending aorta, but no ventricular or valve damage. Dr. will continue to monitor and refer me to cardiologist. Other symptoms include unprovoked fatigue, some shortness of breath, a strange smell of burning plastic and cramping of the upper part of my feet, only at night. Never tested posit positive for COVID with wife and son both had "undocumented" COVID in January and March 2020. They both have antibodies (confirmed with blood testing) and I did not have antibodies. Our physician would not authorize a test for COVID at the time of their symptoms as tests were so coveted and not authorized widely at the times of their illnesses. I really want someone to come forward and confirm the causation and correlation of my symptoms to the vaccine, because I am otherwise an extremely health and active 64 year old with no preexisting or predisposed conditions to widespread PE...not just a clot or two...it is wide spread throughout all lobes of my lungs!

Pt had symptoms start 05/24 including difficulty breathing, chills, 102 fever, pneumonia. Patient was hospitalized from 05/25 through 05/29 for pneumonia and covid.

hot and cold with sweats; hot and cold with sweats; Shortness of breath; Eyes ache and itch a little bit; Headache, like stuffed up, sinus headache; Rattling in chest at night like fluid/ whistling sounds; whistling sounds; A lot of mucus in lungs; got real sick with flu-like symptoms; got real sick with flu-like symptoms; coughing up a lot of; heat flash; feeezing; cold, flu, and pneumonia feel like; chills; joint pain; Severe pain in left bicep; pulled muscle; muscle was tight; Eyes ache and itch a little bit; he was 215 and now 223 lbs. Seems like he gained weight; This is a spontaneous report from a contactable consumer (patint). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 21May2021 13:00 (Lot Number: EW0168) at the age of 64 years as 2nd dose, single dose for COVID-19 immunisation. Medical history included arthritis and pneumonia, had not been diagnosed with COPD, but took a lung test, and was prescribed this symbicort 3 months ago. During the pandemic he was never sick and never had symptoms of COVID, was never hospitalized or none of that. Patient was tested and was negative. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT). Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in left arm on 30Apr2021 (Lot Number: EW0171) at the age of 64 years as single dose for COVID-19 immunisation. Within seven days of taking second shot, patient began to get real sick with flu-like symptoms, started 5 days after he took second shot. Was feeling fine, usually did an hour walk every morning. And 5 days ago, did an extra 30 minutes on his walk to boost himself and that's when he began to get sick. Confirmed date as 26May2021. Still came and went. Stated he developed mucus in his lungs began 27May2021, on 28May2021, got more mucus in his lungs. This past Saturday, didn't buy Mucinex, but got something for severe cold and chest to break up mucus from forming. Patient stated today he was able to start back walking and gradually coughing up mucus. Improving slowly, but surely. Denied shortness of breath. Has rattling in chest at night like fluid, which began on 27May2021. Hot and cold with sweats began on 29May2021 and were not as bad as they were. Stated women should have not men. Shortness of breath began on 28May2021. Not to the point of having to call emergency services. Stated it all came down on him at once. Stated he started to call for ambulance but didn't most emergency rooms sit there for 11 to 12 hours before looking at you or fall out dead. Reported slowly getting better. No sneezing, just felt like he was feverish, but did not have a fever, didn't have a thermometer so he could only go by sweat that he had and the chill he has. Patient stated joint pain that normally didn't bother him. Stated the first shot didn't affect him the way the second shot had. States he now had a little joint pain, like pulled muscles around his lungs, around biceps, sharp pains around biceps. Severe pain in left bicep on 27May2021. His friend thought he was having a heart attack, but wasn't. It was up above heart more like a pulled muscle than a heart attack pain. Patient stated this morning while outside after his walk, all of a sudden a pulled muscle pain in bicep on right side. Stated was this thing moving around on me since started on left side now on right side. Pain had stopped was just a sharp pain, muscle was tight. Stated has never had sharp pains to hit him like that since he was alive. Patient stated he did not have a runny nose, his eyes may ache and itch a little bit, but was coughing up a lot of, had whistling sounds and had a lot of mucus in his lungs. Patient had rattling in chest at night like fluid on 27May2021. Hadn't had runny eyes or stuff in the corner of his eyes. Patient felt like he has gained weight since taking the shot. He was 215 and now 223 lbs. Seems like he gained weight. Patient had headache, like stuffed up, sinus headache from 27May2021. Patient was taking generic brand Tylenol for joint pain. When having chills, he would take 2 in the morning and drink hot coffee. Then all of sudden, went along with joint pain and chills, after moving around and walk outside, broke out into a heat flash. Stated this was irritating. He's freezing one minute and about to burn up the next. Vicks Dayquil pill form for severe cold and allergy to help mucus in chest. Stated he was not able to make it that far to a drug store or Walmart and got from service station. Stated he had had a cold and knew what cold, flu, and pneumonia feel like, what he used to have before this Covid thing. Stated he knew how to recognize some things and not put himself to point of not getting any help. The Symbicort Budesonide didn't do anything to release the mucus. It seemed like it just bypassed that. AEs did not require a visit to emergency room or physician office. Outcome of events got real sick with flu-like symptoms, a lot of mucus in lungs, headache, like stuffed up, sinus headache, hot and cold with sweats, shortness of breath, eyes ache and itch a little bit was recovering, joint pain, muscle pain, pulled muscle, muscle was tight, was recovered and the other events was unknown.

He had shortness of breath and chest pain. He had to go to the emergency room via his wife. When he arrived they performed an EKG and gave him oxygen. He was admitted for 3 days. While there they performed blood tests. They finally treated him on the second day, One doctor thought it was GERD. Another doctor, his cardiologist, thought it was Pericarditis. The first doctor prescribed pantoprazole. The cardiologist prescribed Colchicine. Then he was released from the hospital on June 2nd.

I had painful breathing in the upper right quad of my abdomen. The deeper I took a breath, the more it hurt. The onset was on that Thursday. I am a right side sleeper and I couldn't sleep on that right side. I went back to the surgeon who removed my gallbladder. No treatment was given because no cause of the pain could be found. I started feeling less pain while breathing while I was in the waiting room. Over the next 3 days, the pain got gradually less to a point where it was not hurting at all.

Acute respiratory failure with hypoxia; Acute respiratory failure with hypoxia; Couldn't breathe; Pneumonia due to MRSA/Ground glass pneumonia; weak; lost 20 pounds; fever; Cough; This is a spontaneous report from a contactable consumer (the patient himself). A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6208, Exp 30Jun2021) via an unspecified route of administration in arm left on 16Apr2021 11:00AM (at the age of 64-year-old) at single dose for COVID-19 immunisation. Relevant medical history included heart disease ongoing from 1997 (this happened in 1997 and the patient had been living with it for a little while), heart attack, pacemaker defibrillator because of cardiac arrest (in 2011), atrial fibrillation (diagnosed a little while, he was not sure and had been in and out of the hospital and to heart doctor quite a bit) and hypertension. The patient was administered with first shot of BNT162b2 (Lot number EW0153) in left shoulder on 16Mar2021 11:00AM (at the age of 64-year-old). Concomitant medications were not reported. On 16Apr2021 after the second dose, the patient was fine. There were no reactions after the first dose, but the second dose two days after he started developing a cough and fever. He thought it was a side effect but then ended up in the ER with pneumonia. They gave him antibiotics and sent him home. He went through the antibiotics and went back because he was still sick and not responding. They gave him more antibiotics and sent him home. He went through that batch and ended up really bad so he had to call an ambulance a few weeks later. He was diagnosed with MRSA Pneumonia and stayed in the hospital for 5 days. Then, he was discharged. He went back to the ER again a few days later because he did not seem to be improving. He was coughing and was weak. He was given another batch of antibiotics. He did not know if it was from the shot or what - he was healthy until then. The patient added that she lost 20 pounds and confirmed that it was following the vaccine. Two days after the vaccine, maybe it was 19Apr2021, he had a fever and it was now gone (exact dates were unknown). Cough happened at the same time of the fever but it was not as bad, and then progressively got worse. His lungs started filling up. They thought it was COVID. by the x-rays it looked like COVID lung but they took a sample and it was MRSA (exact dates were unknown). His admission was 18May2021 and was for acute respiratory failure with hypoxia. Discharge paperwork said acute chronic combined systolic diastolic congestive heart failure but he has had that for many years. It also stated primary hypertension but he has had that. The paperwork sayid pneumonia due to MRSA and pneumonia due to unspecified organism. He was hospitalized 18May2021 through 23May2021 with pneumonia and the reason he was hospitalized was because he could not breathe. Lost 20 pounds: after he started getting sick from the beginning of it all, he was coughing and losing weight and all that. It may not be quite 20 pounds, maybe 17, but he just knew that he was down quite a bit. He was 160s now, he was high 170s before (as reported). Treatment included Lasix and all kinds of different antibiotics. They were giving him, he did not know what it was, at first. Then, they narrowed it down and once they found out it was MRSA they gave him Clindamycin he believes. Investigations: they did CT scans, chest X-rays, and labs but he does not know any information. Each time they did a chest x-ray, when he went to get a chest x-ray, each one was worse all the way up to when he was admitted. When he went, they did a bronchial scope or whatever, he was not sure, and they saw lots of swelling and infiltrate. He did not know what this meant, stuff was infiltrating into the tissue and it was not just in the airways. He added it looked like ground glass pneumonia is what they said. The patient added that he was usually pretty active and cannot do anything anymore. He had three or four Covid tests, all negative, no additional details provided. Outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.

Patient stated that the day after vaccine (over 24 hours later) he experienced chest tightness and difficulty breathing. He is still having these issues. I did instruct him to go to the hospital, but he refused at this time.

Chest pain which started 6/17, improved 6/19 and 6/20. Chest pain worsened 6/21 and persisted through the week. Became acutely short of breath and passed away 6/25 at hospital

difficulty breathing during regular activity; This is a spontaneous report from a contactable other hcp (For himself). A 64-year-old male patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Lot number/expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included metoprolol, losartan and apixaban (ELIQUIS). The patient previously took aspirin (e.c.) and experienced drug hypersensitivity. The patient experienced difficulty breathing during regular activity on 29Mar2021. The patient received second dose of (BNT162B2, formulation: Solution for injection, Lot number/expiry date was not reported) on 21Apr2021 at 16:30 in the left arm for COID-19 Immunization. The patient had no other vaccine in four weeks: No. The patient has not tested for COVID-19 prior to vaccination and post vaccination. The patient has not received any treatment. The outcome of the event was not recovered. Information about lot/batch number has been requested.

Sinus problems; Asthma; Congestion in his chest; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in left arm on 24May2021 (at the age of 64-year-old), as dose 1, single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. After first dose, the patient had severe sinus problems. The patient stated this probably began maybe like 2 to 3 days after (in May2021) the patient received the first dose Pfizer COVID 19 shot, maybe later, maybe longer. Could had been the weather change. The patient took some sinus medication and the sinus problems went away. The patient states this went away completely. The patient had asthma. The lady the caller was speaking with that gave the patient the first dose Pfizer COVID 19 shot, said normally some people have sinus problems. The patient stated it started to get in the patient chest, the patient got congestion in his chest. Therapeutic measures were taken as a result of sinus problems and treatment with sinus medication. Outcome of the event sinus problems was resolved on an unknown date in 2021 and rest of the events it was unknown. Information on the lot/batch was available, Additional information has been requested.

June 26, shortness of breath and a heart palpitations. No indication that anything was coming on. Tests performed. Findings, blood clots in left leg and both lungs. Admitted to hospital on June 26. Discharge on June 28. Currently on blood thinners. Sonogram of both legs. Clots found in left leg. EKG, ECG of heart, CT scan found clots in both lungs. Numerous blood draws. Dr. advised I would not have made it to June 27 if I did not come in on June 26. States worst he?s ever seen for blood clots and lungs.

I am an avid runner, averaging 8 mile runs 5-6 days per week at an 8 minute per mile pace. ri an 7 miles after my 2nd covid vaccine and felt fine. 3 days later I started my run, had difficulty breathing, and could not even run a quarter mile. I had my yearly Cardiac Dr appointment, which was done virtually, on 4/15/2021. I mentioned the difficulty breathing during exercise and he ordered Pulmonary CT and chest xray on 4/16/2021. The testing showed I had multiple blood clots in both lungs and was immediately admitted to the Emergency Room where I had a negative Covid test and started me on blood thinners. I was admitted to the hospital and discharged on 4/18/2021. I was placed on Xarelto for a minimum of 6 months, and to follow up with my Pulmonary Dr in 3 months.

07/01/21: cough, fever, runny nose, nasal congestion, shortness of breath, body aches, loss of taste and smell, loss of appetite

One week after first Pfizer shot, had bad heart palpitations, thumping and very noticeable. After two weeks, immediately before second shot, got slightly better. Went forward with second shot. Still have mild heart palpitations ever since, but more like a flutter. But it has been continuous and it's now two months after. Also, extreme fatigue, shortness of breath and mild joint discomfort.

First dose on January 14, 2021 - No adverse events. Second dose on February 4, 2021 - Experienced Anaphylactic Shock. 10 minutes after second shot I experienced lip and tongue swelling, facial tingling, and throat tightening. I was in the waiting room for observation. Symptoms started while in the waiting room. The nurse who monitored the patients saw my reaction. She had to hold me under my arm to help me walk back to the nurses who gave the vaccines. When I arrived, my vision got black and I passed out. I passed out from the reaction to the vaccine. I have a history of Anaphylaxis, I carried episode pens for years. I forgot my episode pens that evening but I carried my own benadryl. I stopped the reaction by drinking liquid Benadryl. I was later transported to the ER via ambulance for monitoring and also for being groggy to the Benadryl. My symptoms from the reactions were: lip swelling, tongue swelling, facial tingling, throat tightening, and sudden loss of consciousness for a few seconds.

CHIEF COMPLAINT: 64 years old gentleman who was recently admitted at another facility with Covid infection discharged 4 days ago presents with shortness of breath HISTORY OF PRESENT ILLNESS: He tested positive for Covid on the 13th of this month (July) and had been at a Medical Center up until last Friday. He did fairly well and was eventually discharged on 2 days of doxycycline. He cannot recall if was given convalescent plasma or remdesivir. He was not discharged on dexamethasone on oxygen. Immediately the next day he felt increasingly short of breath which has progressively gotten worse. When he came to emergency department his oxygen saturations were 89% on room air. Denies any fevers chills but he does have a nonproductive cough.

Headache; injection site pain; loss of balance; mental fog; congestion; breathing difficulty; lethargy; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 02Apr2021 at 08:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD and COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR) and fluticasone propionate, salmeterol xinafoate (ADVAIR) both for an unknown indication and from an unknown date. The patient previously received levaquin for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00, the patient experienced headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of events. The clinical outcomes of the events headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

myocardial infarction; Fluid; Shortness of breath; Chest pain; This is a spontaneous report from a contactable nurse (patient's wife). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0180), via an unspecified route of administration, administered in left arm on 11Jun2021 10:00 (64-year-old at time of vaccination) as single dose for COVID-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There was no family medical history relevant to adverse event. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0186), via an unspecified route of administration, administered in left arm on 21May2021 (64-year-old at time of vaccination) for COVID-19 immunization. There were no vaccines administered on same date with the Pfizer vaccine considered as suspect. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced chest pain on 17Jun2021, fluid and shortness of breath on 25Jun2021, and myocardial infarction on an unspecified date. Patient's wife (a registered nurse, recently retired) just wanted to report this. She can't say that it is the vaccine or anything. Her husband received the second COVID-19 Vaccine on 11Jun2021 and he died at the emergency room 2 weeks later of a cardiac event. She couldn't do the report online because it was making her the one she was reporting on. Chest pain: She took him to the emergency room on 25Jun2021. He had been having chest pain that he reported to her that Monday before. He told her that it actually started the Thursday before on 17Jun2021. He had some chest pain that felt a little better over the weekend, then Monday it was worse. He wasn't a complainer, but he was obviously having chest pain. He was very stubborn and so he just kind of let it progress and it got worse during the week. He wouldn't go to the doctor. She kept telling him she read about myocarditis mostly with adolescent males. She thought what if it is something like that. Time of Onset of Chest pain: He reported it on Monday that he had chest pain on Thursday. She became aware when he woke up at 06:30 on 21Jun2021 and she knew something was wrong when he went for the Ibuprofen. Fluid and shortness of breath: The day she took him to the emergency room the chest pain had worsened and he had fluid and shortness of breath. The fluid and shortness of breath started on 25Jun2021. Death: He died on 25Jun2021. The cause of death was a myocardial infarction. They didn't do an autopsy. The reason they gave for not being able to do an autopsy was they were overwhelmed with drug overdoses and homicides. Indication for COVID-19 Vaccine: He didn't want it, but he needed to go back to the office and didn't want to wear a mask. Adverse events required a visit to emergency room. Investigations: She doesn't have his medical records yet. Essentially they were recording him. She can't believe she got him in in a wheelchair. Immediately they were doing resuscitation efforts. Relevant Tests was reported as none. The outcome of myocardial infarction was fatal; outcome of other events was unknown. The patient died on 25Jun2021. No autopsy was performed. The cause of death was a myocardial infarction. Causality: the reporting nurse has no opinion. She just thinks that the patient didn't randomly die any of his other 64 years. It may be a coincidence.; Sender's Comments: The event myocardial infarction with fatal outcome is considered unrelated to suspect product (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0180). The compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity may explain as alternative cause.; Reported Cause(s) of Death: Myocardial infarction

Congestive Heart Failure; Blurred vision; The caller was concerned the brother may have had an emboli,; Dizziness; Flu like symptoms; He had difficulty breathing/couldn't breathe; Headache; Cardiac issues; Fatigue; The blood pressure keeps spiking; Unable to stand very well; muscle & joint pain; muscle & joint pain; This is a spontaneous report from a contactable pharmacist. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration in deltoid muscle in Jul2021 (Batch/Lot number was not reported, expiration date not provided) at age of 64 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced congestive heart failure on 10Jul2021, blurred vision (Life-threatening) on 10Jul2021 19:30, the caller was concerned the brother may have had an emboli, dizziness (Life-threatening), flu like symptoms (medically significant), he had difficulty breathing/couldn't breathe (medically significant), headache, cardiac issues, fatigue, the blood pressure keeps spiking, unable to stand very well, muscle & joint pain, all in Jul2021. The patient was hospitalized for congestive heart failure from 10Jul2021 to an unknown date. The patient underwent lab tests and procedures which included blood pressure: keeps spiking in Jul2021. The outcome of the events was unknown. Clinical course: The caller was a pharmacist calling in regards to her brother. The caller did not know if this has any correlation. The callers brother received the first dose Pfizer Covid Vaccine, a day later all the typical side effects of flu like symptoms occurred. Had to get up in the middle of the night to raise arms because couldnot breathe: The caller's brother had to get up in the middle of the night to raise his arms because he couldnot breathe. The caller states this occurred the second night after the caller received the first dose Pfizer Covid Vaccine. The caller did not know specifically what time this occurred. The caller told her brother to go to a hospital. The callers brother had every excuse not to go the hospital. Later that evening, the caller called her brother to check on him. The caller's brother was having more symptoms, the brother had dizziness. This was not just typical Pfizer Covid Vaccine symptoms. Ended up in the hospital with congestive heart failure: The patient ended up in the hospital with congestive heart failure. The hospital is still having trouble, this is the patient's second or third day in the hospital. The hospital is having trouble maintaining the patients blood pressure, the blood pressure keeps spiking. This could be coincidental. The caller is asking if anything different is presenting after receiving the Pfizer Covid Vaccine? The caller would like to present this information to the doctor if so. Is there any correlation at all? The caller states she knows there have been incidents of myocarditis, but the caller's brother is not a youngster, the patient is going to be 65 in less than a month. Received first dose vaccine, a day later all the typical side effects of flu like symptoms occurred: The caller states this occurred after the patient received the first dose Pfizer Covid Vaccine. The symptoms have gone away after the third day. The caller has not asked the specific question if the patient recovered with lasting effects or recovered completely and does not know. Had to get up in the middle of the night to raise arms because couldnot breathe: When asked when this began the caller states her brother must have had the first dose Pfizer Covid Vaccine on Friday, 09Jul2021, or it could have been Thursday, 08Jul2021. The caller called the patient on 10Jul2021. When asked if this was ongoing or went away, the caller replies the patient continued with other symptoms that happened. The caller was concerned the brother may have had an emboli, all sorts of things. The caller advised the brother to go to the hospital. Had dizziness: When asked when the patient's dizziness began, the caller states she can not answer that exactly. The caller clarifies the dizziness occurred after the patient received the first dose Pfizer Covid Vaccine. The patient had only received one dose of the Pfizer Covid Vaccine so far. The caller is not sure if the patient has been advised to receive the second dose Pfizer Covid Vaccine or whether this is something totally different. When the patient was having flu like symptoms he was also having dizziness. The dizziness became different the second day at night time at 1930 pacific time, the patient told the caller he went out to the car and got so dizzy and light headed and couldn't breathe. The patient was bringing groceries inside and got winded. It was not normal. Ended up in hospital with congestive heart failure: The caller states the patient was hospitalized yesterday 12Jul2021, the caller then clarifies, no it was Saturday night, 10Jul2021 the patient was admitted to the hospital. The patient is still hospitalized at this time. The caller states she asked the cardiac nurse at the hospital and the cardiac nurse says she thinks this has nothing to do with the Pfizer Covid Vaccine. The caller is not sure and has heard so many different reports. Causality: When asked causality for each symptom, the caller replies, she certainly thinks the flu like symptoms are related to the first dose Pfizer Covid Vaccine. The caller does believe something must have happened to cause his condition to spiral down hill. The patient had some symptoms prior to receiving the first dose Pfizer Covid Vaccine but these were all manageable and not a problem. The caller doesn't know if the patient having the flu like symptoms may have put extra stress on the patient's heart. Had to get up in the middle of the night to raise arms because couldn't breathe: The caller considers this life threatening. Had dizziness: The caller states when the patient had dizziness at night, the caller considered it life threatening. The patient had other dizziness and blurred vision and inability to breathe and it was clearly cardiac issues. blurred vision: The caller does not know when this began. The caller states when her brother called at 1930 on 10Jul2021, that is when he had the blurred vision, the caller does not know if the caller had the blurred vision before and can't answer that question. The caller does not know if the blurred vision is ongoing at the moment. The caller knows the blurred vision had mostly gone away, the caller does not know if any of the blurred vision has come back, she believes it is gone. The caller considers the blurred vision life threatening. Date of first dose: The caller is unable to provide the date the patient received the first dose Pfizer Covid Vaccine. The caller states she would have to be in touch with the patient. It was either 08Jul2021 or 09Jul2021. ~ Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event headache, fatigue, joint pain, muscle pain and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient reported as breakthrough infection requiring hospitalization. Received dose #1 of Pfizer on 3/4/21 and dose #2 on 3/25/21. Patient hospitalized from 7/12-7/15. Below is copied from discharge summary: Pt is a 64 y/o M with pmHx of Afib on eliquis, HTN, chronic HFpEF, anxiety/depression, chronic pain who presented with c/o generalized weakness x 2 days after having an exposure to COVID-19 from a family member. He also reported fever and chills with reported temperature of 102F. He completed COVID vaccine back in March. He tried tylenol with mild improvement. He denied chest pain, cough, SOB, n/v/d, loss of smell, LE edema, orthopnea. He was found to be meeting sepsis criteria in the setting of COVID 19. CXR showed bilateral hazy pulmonary opacities and left sided pleural effusion. Initial vitals showed sinus bradycardia and home amiodarone and coreg were held. He was not requiring oxygen on admit. He was admitted for further management. Procalcitonin was elevated at 0.33 and pt was started on azithromycin and ceftriaxone for possible superimposed bacterial PNA. On 7/14, pt was found to be hypoxic and required 3L of oxygen and was started on Dexamethasone. An echo was done showing mild concentric LVH, EF 50-55%, moderately enlarged RV. He did receive a few doses of IV lasix while inpatient. His home coreg and amiodarone were resumed. He was seen by PT/OT who recommended HH services which was ordered. He was feeling well on 7/15 and back on room air. He passed a walking desaturation study. He had completed 4 days of azithromycin and ceftriaxone and was discharged with Augmentin to complete a 5 day course.

Resident became SOB, congested and hypoxic requiring oxygen, respiratory treatments and suctioning. Stabilized after treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations. Resident was a DNR on Hospice.

Shortness of breath, pounding irregular heart beats, pressure in center of the chest, clumsiness. I had a symptom free case of Covid-19. I took 25 mg instant release Metoprolol beta blocker I keep around for a flutter. The symptoms I had after the vaccine were in no way related to the symptoms I have had with aA flutter. The worst of the symptoms after the covid vaccine lasted from 9:00 pm to 12:00 pm or so when I fell asleep. Diagnosed Positive with Covid-19 on 12/28/2020 by saliva test VAULT TESTING SITE. The day of this Covid-19 Vaccination was my first day off of quarantine.

Patient received COVID 19 vaccine the morning of 1/18/21 at Public Health COVID-19 vaccine clinic. I (person completing this report) work for PH. Later that night while in bed, patient reported difficulty breathing to his wife, then turned blue, and became unresponsive. Family report pt was without any symptoms prior to event. 911 called; CPR started by family member 15 min. after pt became unresponsive. EMS performed resuscitation for about 30-40 minutes with multiple defibrillation for V-fib. Between EMS and Medical Center ER, pt had 9 rounds of epi, CPR w/ LUCAS machine, given 2 doses of amiodarone (150 mg and 300 mg). Patient had 3 EKGs, which did not show STEMI, but did show nonspecific conduction delay and sinus arrest with junctional escape vs sinus bradycardia (HR 50's). Pt had return of spontaneous circulation. Pt intubated, and started on Levophed. Pt transferred to ICU, and had central line placed. Family decided to make patient DNR. Pt went into coarse VFib again, and as per wishes of family, code blue not called. Patient expired at 01:53 on 1/19/21.

1ST EPISODE, 01-15-21 10AM, it happened at the hospital where I work. I was walking flight of steps when i felt i was not getting enough air, i went to sat down and was unable to recover and went to the therapy office to sit down, where a coworker said i didn't look good, my BP 148/92. I felt sleepy, global weakness throughout my body. they took me to the ER where i had an EKG, CBC, thyroid test, angiogap glucose test. The EKG was normal and I stayed about 6hrs in the ER but went home. As the day passed my BP was 122/88 when i got home. I wore a holter monitor for 5 days but don't have results yet. I felt fine for the next 6 days. SECOND EPISODE 01-21-21; i woke up at 5am feeling so sad with despair and feelings of loneliness. I went to work 11:45am, felt fine, sat down to do some work on my computer and I could feel it come up again, went to nurse station and checked my BP 144/90, i could feel my heart pounding and went to the ER again. I felt super foggy and unable to process things. They did a CTA of my neck and chest and a CT with perfusion which was normal. They did lab work and all was normal. THIRD EPISODE 01-25-2021, i was at home happened around 9am, felt fine all morning and then i felt another episode come again. Same symptoms just not as dense as before and texted my wife. I had body aches, felt like I had the flu. I saw my PCP 01-25-2021 (same day as my third episode)and set up an appointment with a neurologist.

Received Pfizer vaccine (dose 1) on 01/23/21 around 2pm. At 10:30pm on 01/23/21 he stated that his chest was heavy and felt like fluid was in his lungs. He coughed up some fluid and mucous. He stated that he had shortness of breath on 01/24/21 and 01/25/21, but has no difficulty breathing since 01/25/21.

Full body flush, head to toe. A bit light headed. A slight wheeze. The clinic was completely unprepared. They showed up with an infant bp cuff. 30 minutes later they showed up with a bp cuff that did not have batteries. I was fine, not particularly concerned but they seemed completely unprepared. That night felt a bit drained. Slept 12 hours . Feel fine this AM.

severe shaking convulsive; chills; nausea; leg cramps; difficulty breathing; vomitting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received single dose of BNT162B2 (PFIZER, Solution for injection, batch/lot number and exp date not reported ), via an unspecified route of administration (vaccine location: left arm) on 22Jan2021 10:45 for COVID-19 immunization. Medical history included diabetes and high cholesterol. The patient did not have Covid prior vaccination. The patient had no known allergies. Concomitant medication/other medications within two weeks included rosuvastatin calcium (CRESTOR), telmisartan, empagliflozin, metformin hydrochloride (SYNJARDY), and atenolol. There was no other vaccine within four weeks. On 24Jan2021 02:00, the patient experienced severe shaking convulsive, chills, nausea, leg cramps, difficulty breathing, and vomiting. No treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.

I was working and around 10 o'clock my back started aching a little bit, and then mild body aches spread all over my body. I started feeling weaker. When I got home I was weak, and I had chills and fever and I was tired. I woke up a few times in the night with night sweats and chills. I was short of breath.

client taken to ER and IV medications administered, client currently taking PO steroids, feels better now and has easier time breathing, PCP instructed client to continue to monitor for reaction and report to ER or PCP,

My throat started closing within 30 minutes. I had difficulty swallowing. It was similar to an anaphylactic reaction I get to nuts. It lasted about three hours.

Within one week of receiving vaccine, experienced shortness of breath and chest tightness on exertion, lightheadedness, tachycardia. Became increasing worse over next 5 days. Visit to ER on 1/18/21. Diagnosed with many bilateral pulmonary emboli with clots in both pulmonary arteries. Admitted to hospital and started on Eliquis. Had doppler on legs which showed DVT.

He received his first dose of Pfizer COVID vaccine today at 12:30 PM. Has h/o Ancef allergy with hives. No h/o anaphylactic type allergies. Waiting in observation area for 15 min. After ~15 min, c/o feeling "shaky". Pt brought back to cot room. BP elevated. Denies unusal SOB, scratchy or swelling in throat. Denies tongue swelling, mouth numbness or tingling. No c/o rash or itching. No visible rash noted. Reports that he has chronic respiratory issues. Brief history reviewed with patient. He reports that he takes glipizide, but can't remember if he took it this AM or not. States he only had one cup of coffee all day. Symptoms progressed to feeling light-headed. Visible shaking of hands with lifting arms. Reports that symptoms were somewhat worsening. After ~15 min more of observation, First Responder was called. ED personnel arrived within minutes. Blood sugar per finger stick was 212. Patient able to ambulate to wheelchair. C/o tingling in scalp and feeling light-headed. Agreed to be transported to ED for further monitoring and possible treatment.

Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death

Pt was visiting dr for routine checkup. Pt began to experience difficulty breathing, 911 called. I showed up to pt apneic, pulseless. CPR initiated. Return of spontaneous circulation in ambulance (without Rx). Pt intubated, ventilations continued throughout contact. Pt still had spontaneous pulse upon delivery ti ED, placed on vent in our presence. Pt later transported to Level 1 hospital on vent.

The patient is a very pleasant 65 year old gentleman with a history of hypertension who presents to the hospital reporting a fever, cough, and chest pain starting two weeks ago. He states that he has had flu-like symptoms for the previous two weeks with a prominent nighttime fever and sweats. He states that he had a similar episode approximately one year ago. He reports that since Saturday he became short of breath. He states that when he goes and feeds the horses and walks back he is short of breath and needs to rest. He denies any myalgias, nausea, vomiting, diarrhea, or abdominal pain. He reports that he has chest heaviness. In the emergency department he was diagnosed with pulmonary emboli with large clot burden. He states that he has never had a blood clot. He has no family history of cancer, deep venous thrombosis, or pulmonary embolus. He denies any melena or hematochezia. He states he has not had a colonoscopy. He reports that over the past two weeks he has not been moving around much, saying that he has been largely confined to his chair due to his illness

Patient woke up at 10:00PM, out of a sound sleep, having an acute asthma attack and generalized itching. No rash. Used Albuterol inhaler twice, 5 minutes apart, and took Prednisone 20 mg orally. Within 60-90 minutes, symptoms completely resolved and did not reoccur. He did not seek medical attention at the time of this reaction, but called this office on 3/11/2021 so that the reaction could be documented. That prompted today's office visit and the completion of this VAERS form. Patient does have monthly allergy injections, but last injection was on 2/23/2021.

started with fever and chills. Progressed over two days to difficulty breathing, migraine headaches, extreme fatigue and periods of seating or feeling very cold

Hard to breath, very bad chest pain and the worst head ache I?ve ever had. All symptoms went away in about 15 minutes.

Pt presented SOB several days prior to receiving vaccine. His sister reported he had severe COPD and was getting progressively worse. On the day pt was vaccinated, his sister picked him up for the appointment and pt refused a wheelchair. Pt walked into the clinic on his own and recevied his vaccine. Sister reported pt walked to the car after his vaccine and was winded. She dropped him off at his house and called him later to check up on him. Pt stated he was feeling fine but his arm was sore. Pt's sister called the next morning and reported that he sounded terrible. He was strugging to breathe and was SOB. His sister went over to his house to check on him and wanted to take him to the doctor's office or the hospital. Pt refused at that time. Pt agreed to make a doctor appointment for later in the afternoon. Sister left at noon. She stated her brother had made a doctor appointment for 4:00 at Family Practice. Upon arriving, pt started walking towards the entrance and became SOB. His significant other asked the doctor's office for a wheelchair and was denied. Pt coded in parking lot of Doctor's Office and passed away at 4:31 p.m.

66 yp, states hes having shortness of breath. Pt is CAO x 3, airway is patent and self maintained. Pt was moved to exam area and vitals were stable. Patient has a history of anxiety, and denies any swelling rash or hives. Present crew determined patient had a panic attack. Crew was able to calm the patient, and care was transferred to ambulance unit.

Patient states that he woke up at 0200 the morning following his first dose of the Pfizer BioNTech vaccine with a sore throat and feeling of fullness in his throat. At this time patient denied trouble breathing or swallowing. Patient arrived to ED via private car around 0330 complaining of difficulty breathing.

No reaction to first dose. Second dose no immediate reaction. 3 days after 2nd shot swelling in the both wrists, at the time I thought it was tendentious. 4-5 Days after, stuffy nose and cold symptoms. 7 days, asthma symptoms began to get worse. Day 9-12 asthma attacks became severe leading to lung congestion, heavy mucus production and intense wheezing and coughing attacks. Treatment during the attacks was FloVent 110 2 puff 12 hours apart. As attacks grew worse, use of Ventolin rescue inhaler had to be used to control severe bronchial constriction and build up of thin mucus causing breathing congestion and more coughing. The coughing and difficulty breathing meant using the Ventolin every hours. The

Immunization 3/29/2021 COVID Vaccine Clinic Need for vaccination +1 more Dx Referred by MD Reason for Visit Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/30/2021 8:12 AM Expand AllCollapse All COVID VACCINE CLINIC 3/29/2021 Patient: (name) DOB: (date) Date: 3/29/2021 MRN: (number) Subjective Patient is a 65 y.o. male who was seen at the COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience shortness of breath as he was walking out to the front. He reports no issues with the vaccine as he was waiting. He denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. Pmh: hx of iron deficient anemia. He just stopped taking his iron supplements on Saturday after being on it for 10 days. He also was taking Diflucan and had some "adverse reaction" of nausea and sleeping issues. Denies hx of heart or lung disease, not on any inhalers or medications for these. Past Medical History: Diagnosis Date ? Fatigue, unspecified type 2/7/2017 ? Impotence of organic origin Impotence, Organic; NG PMH ? Obstructive sleep apnea ? Osteoarthritis ? Unspecified essential hypertension Hypertension; NG PMH ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/29/21 1035 BP: 138/58 Pulse: (!) 102 SpO2: 92% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Heart sounds: Normal heart sounds. Comments: HR improved with rest down to 90 Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Comments: Speaking full sentences. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (headache, itching, tachycardia, hypoglycemia, hypotension, generalized rash) Pt with improvement/resolution of sob with rest. I suspect sob related to iron deficiency. Recommend that he monitor breathing at home . If symptoms return or Worsen, seek care in ED. Certainly to follow up with pcp accordingly for management of his iron levels. Pt voiced appreciation and denies any other questions or concerns. (name), APRN Electronically Signed 3/29/2021 10:42 AM

excruciating joint pain/ had arthritic pain, on thumb, like he broke his thumb then went to toes on left side, it was his whole body, both elbows/ pain in his shoulder; can't lift my left arm for 4 days (injection arm); pain in the joints, even up in jaw bone/ It hurt so bad couldn't eat soup; had a hard time getting around with oxygen.; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 14Jan2021 (Lot Number: EK9231) as single dose for prevention. Medical history included pulmonary fibrosis and dyslexia. There were no concomitant medications. Patient reported "excruciating joint pain after receiving 1st dose Pfizer vaccine. Second dose was scheduled for 04Feb2021. Patient stated that three days after receiving the first dose he had arthritic pain, on thumb - like he broke his thumb (he put on aspercreme and took Advil) but night it went away. The next day my left foot (he put on aspercreme and took Advil), then moved up to his right wrist. same thing. excruciating joint pain and it would move around, it started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows, now he can't lift his left arm (injection arm) for 4 days. There is pain in his shoulder, he can move his shoulder, but to do the chicken wing with his arm, he cannot do it. Got the shot on 14Jan2021, this started 3 days later. To switch positions, from his toes to his knee joints, and it is both sides of his body. His little joints are there one day and gone, he puts Aspercreme on and took Advil, and by night time the pain was gone, but the next day it was somewhere else. The smaller joints, like in his toes and knuckles on his hands, lasted one day, but his knees, bigger joints, was 2 days, his wrists were a day, it even went up to his jawbone, he couldn't suck soup, so it's pretty bad when you can't drink soup. His left arm had been going on for 4 days. He went to his rheumatologist, and the doctor he took 9 vials of blood, because caller's next shot is supposed to be on 04Feb2021, and he was up in the air about getting it with all the pain going on, so the doctor took a look, did 9 vials of blood, and said right now he would not advise getting it until he looked at the bloodwork to see if there was compatible, and the doctor said he would be in touch by the 4thFeb2021. Patient stated he was dyslexic. He also stated he had a hard time getting around with oxygen. Patient stated that he sees a lung specialist for the last 5 years, he has pulmonary fibrosis. Seriousness of the event was reported as non-serious. The patient underwent lab test that includes bloodwork: unknown results on an unspecified date. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

He received his first COVID19 shot (Pfizer) reportedly on 3/2/21, then began a new chemotherapy regimen on 3/10/21. On 3/18, he fell to the floor and could not get up. He was admitted to the hospital for sepsis, pneumonia, and chemotherapy-induced neutropenia, treated on IV antibiotics and discharged on PO antibiotics. His home insulin was also decreased but continued to have hypoglycemic to hyperglycemic events. Insulin was decreased in clinic afterward and was compliant on antibiotics. Returned to hospital again a few days later for sepsis and pneumonia/effusion. He later went to a nursing facility / on hospice. He ultimately required supplemental oxygen and breathing increasingly became labored. Patient ultimately died on 4/9/21.

First covid vaccine on 3/3 and presented to the ER on 3/22 with CP. Second covid vaccine on 4/3 and presented to the ED on 4/15 with complaints of shortness of breath, lower extremity swelling, and 20 pound weight gain x 2 weeks. ED Workup: NT Pro BNP: 558 Hs-cTroponinT: 17>16 CXR: No acute findings EKG: NSR First Degree AVB D-Dimer: 1830 CTA: negative for PE Admitted for HFpEF exacerbation. Treated with IV diuretics, ECHO ordered. Stress test for CP with exertion - negative. Patient still admitted on 4/17/21. ECHO pending.

Patient was recently hospitalized for pulmonary embolism with acute cor pulmonale. First noticed increased shortness of breath on 4/4/21 when shoveling mulch and describes feeling "more winded than usual" with physical activity. He presented to the outpatient primary care clinic on 4/6/21 for evaluation and serum labs and TTE were ordered. Labs were notable for a WBC 13.22 and Cr 0.76. TTE showed hyperdynamic LV function with EF >65% and no tricuspid regurgitation with no concern for right heart strain. A follow-up d-dimer was ordered and returned at 1661 resulting in the recommendation to present to the ED. Upon presentation to the ED, he was hemodynamically stable with an SpO2 of 97% on room air. CT Chest PE protocol was ordered and showed multiple bilateral lobar, segmental, and subsegmental PE with findings suggestive of right heart enlargement was well as areas of pulmonary hemorrhage and developing infarcts. He was given a heparin bolus and he was admitted to the Adult Hospitalist Service. The following morning, patient's hemoglobin remained stable and he continued to feel clinically well. He was transitioned from the heparin infusion to subcutaneous enoxaparin. He was discharged on 4/9/21 with a plan for self-injection of enoxaparin and close follow-up with his PCP.

hypoxic; shortness of breath; opacity in the mid and lower L lung; tachypnoea; tachycardia; This is a spontaneous report from a non-contactable other healthcare professional. A 65-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Mar2021 (Lot Number: ER8734) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2), dose 2 on an unspecified date for covid-19 immunization but reported to have had DOE for the past 3-4 days, has felt fatigued for the past week and his taste seems different over the past couple of days. It was reported that during the 15-minute waiting period after the injection, the patient began to experience shortness of breath as he was walking out to the front. He reports no issues with the vaccine as he was waiting. He denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient complaints of shortness of breath. There was no treatment therapy provided. Follow up response to treatment was excellent (also reported as no treatment provided). The patient was discharged as stable to go home and follow up with PCP (primary care physician). He completed his second dose of Covid vaccine yesterday (29Mar2021). He presented to respiratory clinic earlier today (30Mar2021) and was noted to be hypoxic and was sent to ED. He reported DOE (dyspnea on exertion) for the past 3-4 days and has felt fatigued for the past week. He notes that his taste seems different over the past couple of days. CXR (chest x-ray) on an unspecified date in 2021 shows opacity in the mid and lower left lung. He is tachypnea, tachycardia, high normal WBC and afebrile on an unspecified date in 2021. The patient underwent lab tests and procedures which included chest x-ray showed opacity in the mid and lower L lung and white blood cell count was high normal on an unspecified date in 2021. The outcome of the events was unknown. No follow-up attempts are possible. No further Information is expected.; Sender's Comments: Based on the close temporal association, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of hypoxic cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

History of hypertension and COPD presents to the ED 4/23/21 with complaints of fever, nausea, dizziness, muscle aches, diarrhea, urinary urgency, and shortness of breath that started 4/20/21. SARS-CoV-2 COVID-19 resulted positive 04/22/21 23:40 on PT admitted 4/23/21. PT received dose 1 Pfizer vaccines on 2/25/21 LOT EN6200. Pfizer dose 2 received 3/18/21 LOT EN6207. PT discharged 4/25/21.

Pt reported not feeling well and can not breath well and looks pale Pt's caregiver reported that pt has history of MS and has similar reaction with blood-draw and pt does not have history of allergy to any medications. Pt's O2 Sat was 86% room air and pt was placed on O2 4L via nasal cannula and O2 sat: 100% room air. BP; 60/32, HR: 44, R: 18. 911 was called and patient transported to Caregiver took patient's belonging. 911 called, patient taken to ED. Cancelled 2nd dose, scheduled Johnson & Johnson appointment.

Same day symptoms fever, myalgia, arthralgia, shortness of breath, leg swelling, transaminitis, hyponatremia. Found to have pericardial and pleural effusions. Proteinuria and hematuria on urine test. Kidney biopsy performed confirmed diagnosis of fibrillary glomerulonephritis. Diagnosed with serum sickness like reaction

severe pain at injection site; shallow breathing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: E13302), via an unspecified route of administration, administered in left arm on 10Feb2021 at 10:00 (at the age of 65-years-old) as single dose for COVID-19 immunisation. The facility type vaccine was hospital. The patient did not received other vaccine in four weeks. Medical history included cancer, COPD and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included clopidogrel bisulfate (PLAVIX), metoprolol, atorvastatin and gabapentin, all taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 the patient experienced severe pain at injection site and shallow breathing. The patient did not receive treatment for events. The outcome of events was not recovered.

Patient received vaccine on tuesday 5/4. Patient developed a rash surrounding both ankles. Patient and wife dismissed this as possible side effect of vaccine. The patient had difficulty breathing and dismissed it as a panic attack on 5/10. Symptoms continued for several days, went to walk-in clinic on Wednesday 5/12 for tests and inconclusive. Thursday 5/13 the patient continued to experience these symptoms and elevated pain, tightness and cramping in legs and went to the ER where he was diagnosed with bilateral pulmonary emboli. Patient was admitted for 2 days and treated for clots. Upon discharge the patient was instructed to discontiue meloxicam, carbidopa/levodopa and started on eliquis for 6 months. After 6 months the patient will follow-up with a hemotologist.

Client tested positive for COVID on 5/10/2021 after being fully vaccinated. States he started having a cough on 4/24, no other symptoms reported except for one episode of SOB on 5/13 while in the hospital (not for COVID).

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient came to pharmacy and stated that his doctor looked at his medical history and said he can get a COVID vaccine. Answered questionnaire and stated no allergies to anything. Gave pt the vaccine, and then patient told us that he had history of Guillain-Barre Syndrome. Gave patient cold water. Patient requested some table salts and 2 tabs of 25mg diphenhydramine. Patient refused Epipen and calling 911. He sat for at 45 minutes to an hour before leaving. He said he was feeling okay when leavin

Office Visit 4/30 Suspected COVID-19 virus infection +2 more Dx Fever ? Cough ? Sore Throat ? Dizziness ? Headache Reason for Visit ED to Hosp-Admission Discharged 5/1/2021 - 5/5/2021 (4 days) Last attending ? Treatment team COVID-19 Principal problem Discharge Summary INPATIENT DISCHARGE SUMMARY . Date: 5/5/2021 Length of stay: 4 Days Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) COVID-19 Yes Hospital Course HPI: 65-year-old man admitted with COVID-19 pneumonia Hospital Course: This man was admitted with COVID-19 pneumonia. He had a possible bacterial superinfection. His procalcitonin was elevated. We therefore treated him with antibiotics for the bacterial superinfection, and treated him with convalescent plasma, remdesivir, and dexamethasone for his Covid infection. Patient is doing much better now. He is breathing well on room air and feels ready to go home. Physical and Occupational Therapy saw him and they recommended home health at discharge. We are talking to the patient about whether he prefers to go to a inpatient rehabilitation facility versus home with home health. That is still up in the air at this moment we will follow whenever pathway is most appropriate. The patient did have some elevated liver function test on admission but these are better at the time of discharge. He also has continuous narcotic dependence and is getting frequent opioids. This is keeping his chronic back pain under control. On the day of discharge the patient is feeling very good and is eager for discharge.

4-28-2021 DOS Chief Complaint: Pt states he is here for f/u Covid + Test on Saturday PCR. HPI: 65 y/o M with COVID x 5 days states he does not feel right, is short of breath. Pt reported completing Pfizer series, Vaccination facility: unknown, vaccination and manufacturer dates gathered/confirmed: 1-23-2021 and 2-13-2021 Vitals: o2 sat 87% went up to 90-93% after sitting for 5+mins, pt was sent to ER for evaluation Per Hospital discharge documents, pt was given two doses of Remdesivir on 4-29-2021 and 4-30-2021. Pt was discharged home on O2. Pt had hospital follow up appt at our facility: on 5-7-2021: . Vitals for this visit: sats 92 without O2 and higher when on it. He uses O2 when watching Tv and at night. On 5-24-2021, pt asked as to how he would classify for continuing O2 supplementation. Provider advised of testing that would need to completed to order O2 tx continuation.

Positive COVID-19 test on April 24th, and on April 28, 2021. Hospitalization on April 28th with Pneumonia due to COVID-19 virus, COVID, Hypoxia, Acute respiratory failure with hypoxia (HCC)

Blood clots causing pulmonary embolism on 3/29 . Hospitalized on 4/6-4/8. Clots also caused a mild stroke on 5/5. Hospitalized 5/5-5/6

Pt in the clinic with caregiver for 1st Pfizer vaccine at 955am. Pt is sitting in mobile scooter and NP was called by staff. Upon arrival, pt reported not feeling well and can not breath well and looks pale. Pt's caregiver reported that pt has history of MS and has similar reaction with blood-draw and pt does not have history of allergy to any medications. Pt's O2 Sat was 86% room air and pt was placed on O2 4L via nasal cannula and O2 sat: 100% room air. BP; 60/32, HR: 44, R: 18. 911 was called and patient transported to outside hospital at 10:20 am. Caregiver took patient's belonging. 10:10 am BP: 83/44 HR: 54, R: 18, O2 sat 100% 4L NC 10:13 am BP: 67/42 HR: 56, R: 18, O2 Sat: 100% 4L NC 10:16 am BP: 71/46 HR: 55 R: 20 O2 sat: 100% 4L NC"

Pt received his second dose of Pfizer COVID vaccine on 5/19. That same day he developed diarrhea and shortness of breath. He presented to hospital emergency department on 5/23. They recommended COVID test, but patient refused and he was discharged home. He re-presented to ED on 5/26 and was admitted and treated for bacterial pneumonia with CTX/Azithromycin. During that admit he was newly diagnosed with Atrial fibrillation. Discharged on Eliquis. He then re-presented on 6/2 and tested positive for COVID. Pt got upset with the diagnosis, refused care, and left hospital. His daughter lives in the northwest suburbs, so she brought him to Hospital, where patient also tested positive for COVID on 6/4 and was admitted for COVID treatment (noted to be hypoxic (89% O2 sat) on room air).

march 9th received first vaccine, march 20th woke up coughing and couldn't breathe, went home after work and did teledoc who recommended the emergency room. Tested negative for COVID, bipap provided. was in the hospital for 7 days states, "half the heart stopped working" and was diagnosed with heart failure. EF is 30-35%. Is having a nuclear medicine test Friday to evaluate if further intervention is needed. Stress test two years ago was normal

shortness of breathe / hard time breathing / difficulty of breathing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported via Medical Information Team. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot/batch number and expiration date were unknown) via an unspecified route of administration on 09Feb2021 as single dose for Covid-19 immunization. The patient medical history was allergic to fish oil and Zocor. The patient's concomitant medications were not reported. On 10Feb2021, patient experienced shortness of breathe / hard time breathing / difficulty of breathing later and was seen by urgent care on 14Feb2021 for shortness of breath and difficulty breathing. Patient received his first Pfizer covid vaccine on 09Feb2021. He experienced some shortness of breathe later & was seen by urgent care. Patient received steroid injection (unsure of the name) when seen at Urgent Care and a prescription for an inhaler. Patient asking that if he should still receive the second dose of Pfizer covid vaccine. Patient had a hard time breathing after 1st dose. The patient was asking how long will the difficulty of breathing less. He was experiencing heavy breathing at the time of reporting. Patient received steroid injection (unsure of the name) when seen at Urgent Care and a prescription for an inhaler and prednisone. Patient had an x-ray (negative for any findings per patient) and was prescribed prednisone. Patient reported that the symptoms got better but never went away. The patient underwent lab tests and procedures which included x-ray: negative on 14Feb2021. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

Out of sorts and dizzy; Out of sorts; Heaviness in his upper chest and shoulders; Heaviness in his upper chest and shoulders; Felt wobbly; sneezed 4x in rapid succession then he felt like he couldn't breathe; Felt like his heart or left lung was going to burst; Aches and pains in his body like he had the flu; Sneezed 4x in rapid succession then he felt like he couldn't breathe; This is a spontaneous report from a Contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264) via unspecified route of administration, administered to right shoulder, on 04Feb2021 at 9 AM, as unknown dose, single for COVID-19 Immunisation. Medical history included bipolar disorder. The patient's concomitant medications included testosterone undecanoate (AVEED) taken for hypogonadism, start date was unknown and it was ongoing; Lithium Carbonate taken for Bipolar disorder, start date was unknown and it was ongoing; Valproate semisodium (DEPAKOTE) taken for Bipolar disorder, start date was unknown and it was ongoing; lurasidone hydrochloride (LATUDA) taken for Bipolar disorder, start date was unknown and it was ongoing; Levothyroxine sodium (SYNTHROID)taken for Hypothyroidism, start date was unknown and it was ongoing; Pantoprazole taken for Gastrooesophageal reflux disease (GERD), start date was unknown and it was ongoing; quinapril taken for blood pressure high, start date was unknown and it was ongoing; Metformin taken for diabetes, start date was unknown and it was ongoing; Mirabegron (MYRBETRIQ) taken for Urine abnormality, start date was unknown and it was ongoing. Caller stated that he had adverse effects immediately after getting the injection. On 04Feb2021 (also reported as: less than 30 seconds after the injection), the patient experienced like out of sorts and dizzy. He stood up and walked to the observation area and had a heaviness in his upper chest and shoulders and felt wobbly. After 15 minutes, he stood up and went to his car and felt almost normal. When he got home, about 2 hours later, he sneezed 4 times (4x) in rapid succession then he felt like he couldn't breathe. Stated that he had to try to stay calm and tried to relax, and almost immediately it felt like his heart or left lung was going to burst, but it went away after a second. Stated that about 2 hours later he had aches and pains in his body like he had the flu, and that lasted for about 30 minutes, then they went away. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 04Feb2021 at 2:30 PM, the outcome of the events were recovered. Follow-up attempts completed. No further information expected.

After a few days very fatigue, went to get a sleep study and doctor said he needed a sleep pap machine The sleep study was completed on 4/20/21. Also had shortness of breath on after shot called pcp on 4/23/21 and told him to go to the ER. Went to ER pulse rate was high and showed signs of a heart attack. Stayed over night got a echocardiogram and he passed out as he was trying to walk on 4/24/21. 4/25 echocardiogram turned out good. 4/26 found blockage in heart and was told he needed bypass surgery. He had surgery 4/28/21 during heart surgery they did and ultrasound on the artery between the lungs and he had a 4 inch saddle embolism which they removed and continued with the heart surgery. All his problems was actually caused by the embolism.

Pt. is a 65 yrs. male with h/o renal transplant on immunosuppressive therapy, presenting with worsening productive cough of white sputum for the past couple of days. There is associated fever, chest pain while coughing, shortness of breath, sore throat, painful swallowing, chills, and generalized body aches. Had one episode of non-bloody emesis and watery stool. Denies change in urinary habits, no dysuria. He went to minute clinic at store pharmacy and an X-Ray showed RRL pneumonia per radiology report he is holding, got one dose of azithromycin, came her for worsening symptom. Portable X-Ray in ED was negative for infiltrate, he was febrile and tachycardiac. He is fully vaccinated for covid 19. Hospital medicine was asked to admit the patient for further evaluation and management.

I had the second dose on 03/27/2021. I got the main symptoms of headache, body aches, pains the following day. I went to urgent care 3 days later, Tuesday 30th. Went in for pain I thought I had a rib out, they had a chiropractor checked me out, he did not do anything, I went to urgent care twice. Both times my lungs were clear. No pneumonia. They did an x-ray which was clear. I had nebulizer treatment, and then it came back to the same. I went to the doctor the following week on 04/13/2021 and he checked me over and could not find anything. He heard some crackling in the lower part of my lungs, which he found interesting but he could not find out why I was having that pain. I left there. Before getting home he called me and said that it could be a sign of a blood clot. He had me get a CT scan, I got it in 06/14/2021. They found that I had 1 blood clot on each lung. The biggest one on the right one. They gave me blood thinners. I had fluids on my lungs. They were not able to take it all out so I might have to have surgery. The blood clots have resolved themselves with the medication.

65-year-old with history of TBI and end-stage renal disease subsequently initially admitted to the floor secondary to fever and chills. Found to have COVID-19 pneumonia. On June 13 a rapid response was called for worsening respiratory failure. Subsequently transferred to ICU. Initially on CPAP at 100% FiO2. CTA negative for PE but did show diffuse ground glass infiltrates. Completed 10 days of dexamethasone. Not a candidate for remdesivir given end-stage renal disease. Additionally on cefepime and Rocephin for 10 days subsequently restarted on meropenem. Fortunately patient continued to have hypoxemia unresponsive to noninvasive ventilation. He was intubated on June 19. At the time of intubation he expresses desire not to be intubated for an extended period of time. Unfortunately they are unable to wean from ventilator. Remains on 100% FiO2 with PEEP of 18 and was on nitric oxide. In addition was on paralytics. Remained on prednisone taper off of dexamethasone. In addition to above patient had complications A. fib with RVR further complicated by hypotension. Was on 3 pressors. Suspect multifactorial to sedation and patient with severe Covid who also has end-stage renal disease. SLED initiated while in-house. On the afternoon of June 23 palliative team did meet with patient's siblings. That time determined to transition to comfort care. Compassionate extubation performed. Patient passed away shortly after extubation. Patient died of COVID-19 despite being fully vaccinated against it. Death Certificate Information: Part I: Cause of Death A. Respiratory Failure B. Pneumonia C. COVID-19 Part II Other Significant Conditions: Hypertension, Diabetes Mellitus Type 2, End Stage Renal Disease

Headache; fever ranging from 99 - 101; Shortness of breath; Fatigue; Body ache; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 04Mar2021 at 15:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), obesity, type 2 diabetes, asthma and COVID-19 in Mar2020 and Apr2020. It was reported that the patient was on unspecified concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 02:30, the patient experienced, headache, fever ranging from 99 - 101, shortness of breath, fatigue, body aches, nausea, vomiting, and diarrhea. The symptoms lasted for about forty hours after they began. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures taken included tylenol (MANUFACTURER UNKNOWN) for fever and ondansetron (MANUFACTURER UNKNOWN) for nausea. The clinical outcome of the events headache, fever, shortness of breath, fatigue, body ache, nausea, vomiting and diarrhea were resolved on 07Mar2021. No follow-up attempts are needed. No further information is expected.

65 y.o. African American male who suffered from COVID-19 PNA earlier this year, as well as MRSA endocarditis with septic brain emboli and fungal empyema. He was in rehab and presented to SMC ER with persistent cough without fever x 1 week, and associated chest pain. He states he was unable to produce sputum for some time, but he has finally been able to expectorate clear/ yellow phlegm in the last day or so. The cough disrupts his sleep. He notes pulmonary wheezing.. He smokes 2-3 cigarettes per day at this time and does not use any inhalers. He also reports persistent diarrhea and new right foot swelling which started morning of admission. Patient reported being fully vaccinated for COVID19 and was found to be positive via PCR. His CXR showed CM, central vascular congestion, RT small effusion/atelectasis, but no infiltrates and no clear pneumonia. The patient was discharged to a SNF 7/2/21.

Dizzy; labored breathing; headache; body aches; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6955) via an unspecified route of administration in the left arm on 26Mar2021 at 17:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 17:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 17:00, the patient experienced dizzy, labored breathing, headache, body aches, and soreness at injection site. and it was felt like he had hit by a truck within seconds and most symptoms had passed in intensity during 15 minutes waiting period. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events dizzy, labored breathing, headache, body aches and vaccination site pain were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

I had flu-like symptoms after the first shot; Achiness; chills; sore muscles; difficulty breathing; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received the first dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 at 12:15pm (at the age of 65-years-old) as a single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, on an unspecified date in Mar2020 patient had affected with covid-19 and unknown if ongoing. Since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Albuterol Sulfate which was prescribed in last year. The patient reported that on 20Mar2021 at 01:00 AM he had flu-like symptoms after the first shot, the patient had achiness, chills, sore muscles and difficulty breathing and those subsided within 24 hours. The patient received second dose of vaccine on 19Mar2021 at 12:15 PM (Batch/Lot: EN6207). The patient was recovering from the events. No follow-up attempts are needed. No Further information is expected. .

This case meets vaccine breakthrough criteria review with +COVID test >14 days post vaccination series. Presented to ED with shortness of breath, myalgias, fatigue, nausea, abdominal pain, cough, vomiting, diarrhea

He felt slightly unwell after the first dose of vaccine but recovered after a day or two On evening of 2nd dose, he developed severe chest pain, shortness of breath, and generalized malaise, without fever or cough. He requested to see me after 5 days of symptoms getting worse such that he felt short of breath doing very little, like walking just up a few steps, or talking, I saw him on 7/19. his physical exam was grossly normal, although he reported presence of pressure on the chest and shortness of breath with walking and talking. After blood test finding elevated BNP, I tried to get him to schedule an echo, and sent Rx for diuretic. But he got too short of breath at home and called 911. When the ambulance arrived, he was not to the hospital I was affiliated with, but another hospital nearer to his home, so I have no direct assess to his record, but at the time of discharge 4 days later, I spoke to his discharging hospitalist to obtain the full medical course, in addition to his own account.

after second dose the shortness of breath and difficulty breathing began to get worse; challenging for him to walk around as he normally could; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration (at the age of 65-year-old) on 02Mar2021 (Lot number: unknown) as single dose for COVID-19 immunisation. Medical history included allergic to fish oil. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration (at the age of 65-year-old) on 09Feb2021 as single dose for COVID-19 immunisation and experienced shortness of breath and difficulty breathing. The patient previously took simvastatin (ZOCOR) and experienced allergic. Patient reports that he received both dose of vaccine. First dose on 09Feb2021, second dose 02Mar2021. Patient had an x-ray (negative for any findings per patient) and was prescribed prednisone. Patient reports that the symptoms got better but never went away. Patient states after second dose the shortness of breath and difficulty breathing began to get worse again. Patient also mentions is challenging for him to walk around as he normally could. Patient states he was fine until he took the shot and he needs to know what he was supposed to do. Caller reports that he cannot afford to got to hospital. Patient would like to know how long his symptoms will last, if his lungs are good then what can it be. Patient got the 2 doses of Pfizer covid-19 vaccine, he stated that he was experiencing difficulty of breathing (DOB) and he wants to talk to a pharmacist to know what was the cause why he had that on an unspecified date in Mar2021. The patient underwent lab tests and procedures which included x-ray: negative on Feb2021 negative for any findings per patient. Therapeutic measures were taken as a result of after second dose the shortness of breath and difficulty breathing began to get worse. The outcome of the event dyspnoea was not recovered and other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

he couldn't take a deep breathe; smothering feeling; felt an out of body; light headedness; This is a spontaneous report from two contactable physician received via Medical Information Team. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right shoulder on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that: "on 23Dec2020, a minute after vaccination he felt as if he couldn't take a deep breathe, it was like a smothering feeling, then he felt an out of body and light headedness, this only lasted for 3 minutes". The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test which resulted negative and SARS-CoV-2 test: no positive results for the COVID Test prior to the vaccine. The patient outcome of the events was recovered. Information on the lot/batch number has been requested.

1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased

Developed pulmonary embolism in right lung one week after vaccination. Sharp pain on right side when breathing. Treated with IV Apixaban while inpatient for 2 days, oral Apixaban 5 mg, 2 tabs twice daily 1/5/21-1/11/21, then one 5 mg tab twice a day. Pain has subsided as of 1/14/21.

Approximately 9 hours after injection, I was awakened with heart pounding in my chest and it felt fast but I did not check it. Watch did not show higher than 84 through the night but I could not sleep much due to the heart pounding. Arose for work at 6:15 and felt tired but the palpitations did not bother while standing. Temperature 98.8. about 90 minutes later, while at work, HR was 130-148, I was breathing deeply, otherwise okay. Chills started about 17 hours post-injection and temperature rose as high as 102.4 in the next 3 hours. HR lowered to about 110 about 16 hours post injection and did not get below 100 for another 12 hours. some coughing throughout this time, not productive. Heavy night sweats around 34 hours post injection. I had mild chills about 48 hours post injection, and fine since then. The palpitations were very uncomfortable but stopped once the HR lowered to about 110

chills; severe shortness of breath; rapid heartbeat; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283) via intramuscular at right arm on 11Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and experienced sinus infection from 24Dec2020 and recovered on 31Dec2020, he went through antibiotics for a week for the sinus infection which was completed by the second dose. Patient works in a hospital laboratory. He wanted to report a reaction/side effect for Pfizer COVID 19 vaccine. Stated this was his second dose. The reaction started 12 hours post vaccination of chills that went overnight (12Jan2021). Stated that it was followed by severe shortness of breath at about 4 to 5 AM and rapid heartbeat. He was advised to get tested and was negative (undated). He also had headache and fatigue, all on 12Jan2021. Stated that he had gotten his second dose at 14:00 on 11Jan2021. Stated that he never experienced anything like on 12Jan2021 that he was literally frantic. Outcome of fatigue was recovered on 13Jan2021, outcome of other events recovered on 12Jan2021.

Apprx 7 minutes after receiving vaccine, I experienced a sensation in my chest, upper arms, and neck areas. I also experienced a slight metallic taste in my mouth. I also sensed a somewhat increased heart rate and some slight dizziness. I did NOT experience any breathing difficulties but maybe had a very slight wheeze sensation. These reactions lasted only about 8 to 10 minutes then started easing away. I was monitored a full 30 minutes and then released after reporting I felt ok then.

Progressive, dull anterior/posterior chest pain onset 1/26/2021. Pain worse with deep inspiration. Symptoms similar to that experienced with prior pleuro-pericarditis. Few episodes of palpitations which abated with cough or Valsalva. Initiated high dose ASA and colchicine on 1/28/2021. Symptoms abated by 2/03/2021.

Patient with past medical history of CAD, CKD, sCHF, LGL Leukemia admitted to Hospital on 1/19 with pleural effusion. Pt expired on 2/1/2021. Hs of essential HTN, complete heart block, T2Diabetes,thyroid issues, stroke, papillary CA of thyroid, dyslipidemia, anemia, hypercalcemia, pulmonary nodule, hypoparathyroidism, pacemaker, bilat carotid stenosis, afib, pleural effusion, pancytopenia, cardiomyopathy, severe aortic stenosis, sick sinus syndrome, Dressler syndrome, empyema, ESRD

DVT and probable pulmonary embolus based on hypoxia Patient is physician who cares for patients in NH and ALF where there is documented COVID First dose COVID vaccine 12/20/20, second dose 1/10/20 Some shortness of breath developed about 1/10, not severe 1/30 Leg pain, fever to 101.6 abrupt onset extreme fatigue, ER eval 1.31 negative eval including neg rapid and PCR COVID tests Persistent sx led to repeat ER eval including LE dopper confirming occlusive femoral vein thromboxis; no hypoxia at rest but desat to 85% on exertion (climbing one flight of steps) Started anticoagulants 2/4/21 on home treatment; not working since 1/30/21

Patient stated they were becoming dizzy and lightheaded. Immediately had patient come into vaccine room to see what else was happening. Patient stated they were also having breathing difficulties. Immediately tested patients bloods pressure. Tested twice and came to 220/120 with heart rate 80. Was an emergent situation. Informed patient I was contacting 911 to have them take him to the hospital as this is an emergency situation. Went and made phone call. Had staff bring patient into waiting area so that we could monitor him if something worsened. 911 advised to just monitor the patient. If he began vomiting or passed out to have him on his side, so he doesn't choke from vomit. We monitored patient until ambulance arrived. They asked for current medications we knew of (listed in report) and that he had received Pfizer Covid vaccine 0.3ml resulting in emergency BP readings of 220/120 after receiving. Ambulance took patient to Hospital. Current condition unknown or if anything even occurred after that point. Whole event lasted about 1 hour before patient left with medical personnel.

on 2/1/21 at ~7AM pt was noted by the RN to have rt sided weakness & was sent to Hospital ED for evaluation. They felt he could have had a TIA, or extension of a prior CVA (nothing new on MRI, has small vessel ischemic disease), or a COVID vaccine reaction. Symptoms have mostly resolved, he is not always cooperative so subtle weakness is difficult to detect. He was hospitalizaed, started on ASA & increased BP meds, and returned to his home, where he has resided for several years.

unable to take a deep breath, or any deep breath, with sharp pain under right shoulder blade. Symptoms were the same as previous pneumonia episode. also the body aches all over, somewhat severe. Body aches lasted 72 hours with decreasing after 24. Breathing lasted 96 hours with decreasing after 48.

Had chest pain ("lung pain") the day after vaccination, then 2 days after the shot, he experienced some dizziness and nausea. Dizziness and nausea lasted for 3 days and 3 nights. Chest pain persisted and seems to be getting worse. Severity 3/10 - 7/10. + pain with movement, none at rest. No dyspnea, shortness of breath or fever.

Gentleman received his 2nd dose Pfzier Covid 19, and 10-15 minutes later complained or trouble breathing. Had him sit down, called 911 and monitored breathing. Said he started feeling better and when EMS showed up they took vitals and suggested the gentleman go to the ER for further evaluation to make sure he was ok. NO Benadryl/epinephrine was administered.

Patient c/o general weakness, dyspena, lightheadedness. No increase in resp effort. Vital signs: 92/62-52-14-96% O2 Sat. Alert and orients. Skin cool and clammy. Breath sounds clear. Cap refil 4 sec. Laid supine. Monitored patient for 35 min. Vital signs: 132/88-70-96% O2Sat. Patient returned to basesline. No dizziness or lightheadedness. Patient discharge home.

After getting my Pfizer second shot. 15 hours later I began to get itchy through I whole body. And the swelling of my glands in my throat. Went to the ER to get treated. I was medicated with different antihistamines. And I was observed for five hours. The swelling of the glands didn?t go down some what. But I am still itchy not as drastic as it was yesterday Monday, March 1 of 2021. But my body is still itchy. Medication?s are Benadryl, famotidine, and prednisone. I will be seeing my family doctor this afternoon as a follow up from yesterday because I am still itchy most around my body. No fever, no bodyaches, but the itching Has not some subsided.

The patient presented yesterday to an urgent care center on 3/11/2021 with chest pain, jaw pain, and shortness of breath. He reports multiple occurrences over the past week. He was sent to the ED, where he was then admitted for hypertensive urgency/emergency vs. unstable angina.

Awoke March 8 with vertigo dizziness such that I could not walk without assistance or plus asthma symptoms. Took meclizine and stayed in bed till March 10. Symptoms subsided on March 11 but continued absence from work & very limited activity until the 12th. Symptoms are better but still not completely recovered

He woke up this morning and felt awful; He is mainly fighting fatigue now and feeling rough; His sinuses shut down yesterday; muscles hurt and legs hurt; muscles hurt and legs hurt; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; This is a spontaneous report from a contactable consumer reported for himself. A 66-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9269 via unspecified route of administration at the left shoulder on 08Feb2021 11:00 AM (at the age of 66-years-old) for COVID-19 immunization. The patient received the vaccine at hospital. Medical history included a bypass surgeries (18 stents), a chronic obstructive pulmonary disease and he donated a kidney in 1997 and immunosuppressed. The patient had COVID at the end of December.Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81 mg, 1x/day, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) 1x/day (200/25 one puff), sacubitril valsartan sodium hydrate (ENTRESTO) twice a day, fenofibrate 160 mg, 1x/day, isosorbide mononitrate (IMDUR) 120 mg, 2x/day, metolazone 5 mg, 1x/day, as needed, metoprolol 100 mg, 2x/day, famotidine (PEPCID) 40 mg, 2x/day, clopidogrel bisulfate (PLAVIX) 75 mg, 1x/day, potassium (POTASSIUM) as needed, 10mEq, evolocumab (REPATHA) 140 mg, biweekly, ranolazine (RANEXA) 1000 mg, 2x/day, montelukast sodium (SINGULAIR) 10 mg, 1x/day, torasemide as needed(40mg up to 160mg ), colecalciferol (VITAMIN D [COLECALCIFEROL]) 50,000 units once a week, nitroglycerin. On 08Feb2021 about midnight, he woke up and had shortness of breath and chest pain, he took 6mg Nitro and he took two at midnight; He took another one at 1:00AM and it had pretty much gone away. Around 2:30AM the chest pain hit again big time, he woke up on morning and felt awful. On 08Feb2021 his muscles hurt and legs hurt. He was mainly fighting fatigue now and feeling rough. His sinuses shut down on unknown date. The patient recovering from muscles hurt and legs hurt and recovered from chest pain. The outcome of the other adverse events was unknown.

Non-productive cough, shortness of breath, increase in blood pressure (170/90) and increased heart rate (85 bpm). Symptoms began shortly after second dose of vaccine on 2/26/2021

2/27 Patient presented to a Clinic with ~4 days of nausea, chills, muscle aches and fatigue. He was diagnosed with COVID-19. He continued to feel poorly and 3/1 was started on doxycycline as an outpt. 3/3 was started as outpt on dexamethasone. 3/6 Presented to ED w/ worsening symptoms including SOB. RA pulse ox was 88%. He was admitted for COVID/COPD exacerbation and was changed to IV azithromycin/rocephin and dexamethasone. He was maintained on oxygen. He was unable to be weaned off oxygen and was discharged to home on 3/9 on oxygen.

Patient presented to oncologist on 3/5 with SOB, fatigue, increasing lymphadenopathy from chest CT on 3/4/21. Patient was prescribed a pulse dose of steroids. Patient was admitted to the hospital, lymph node biopsy was performed demonstrated active disease. Patient also had active EBV virus. Patient was started on IVIG which resulted in an increase in platelet count. Patient will be initiated on rituxan therapy this is being treated as an EBV lymphoproliferative disorder. Brentuximab therapy will be held.

Pt received shot at 1222. At 1241, pt reported symptoms of feeling like he was ?at high altitude, where it?s just a little bit harder to breathe.? Pt reports that he just got back from a ski trip and likens the sensation he?s feeling now to being at high altitude. BP 160/82, P52, O2 98%RA, Temp 98.9F Pt reports hx Afib. Lung sounds clear bilaterally. EMS on site and assessment was offered. Pt declined EMS assessment at this time. Pt was offered benadryl by staff and pt was advised that this might make him sleepy. Staff offered to call a friend/relative to drive him home. Pt told staff that benadryl does not make him sleepy and he took this at 1255. Pt advised to wait 30 minutes to see if symptoms resolve. At 1313, pt reported that symptoms have improved and he asked to leave. Recheck bp 160/78, O2 98%RA, Pulse 47 (pt states low pulse is normal for him). Pt advised to follow up with PCP prior to 2nd dose. Pt states that his wife is a nurse and she will be home to take care of him. Pt left vaccination site with no signs of distress noted. Calm, cooperative, A&Ox4, and fully conscious.

fluid retention required a visit to the emergency room; shortness of breath; fluid retention; This is a spontaneous report from contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN9581), via an unspecified route of administration on 04Feb2021 at 09:00 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family history was denied. However, the patient did say that he had fluid retention prior to the vaccination (duration not specified). The patient further reported that he had illness at vaccination; he specified that he was experiencing fluid retention when he got the first dose of the Pfizer COVID 19 vaccine Concomitant medications were not provided. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports that he had fluid retention and shortness of breath and was admitted to the hospital "the week of 20Feb2021." He was discharged that weekend, on Friday. He knows it was that week because on 25Feb2021 he was supposed to get the second shot and he missed it because he was in the hospital. He has fully recovered now from the fluid retention and shortness of breath. Adds he had the fluid retention prior to receiving the first dose of the Pfizer COVID 19 vaccine and was experiencing fluid retention when he got the first dose of the Pfizer COVID 19 vaccine. The received unspecified treatment for the events. The clinical outcomes of the events fluid retention and shortness of breath were reported as recovered on 27Feb2021.

had serious COVID 19 symptoms after the second shot; had serious COVID 19 symptoms after the second shot; serious trouble breathing and wheezing with every breathe; serious trouble breathing and wheezing with every breathe; severe body aches; sever chills; mild fever; cold sweats; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:15 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, covid-19 from Mar2020 to an unknown date. Albuterol Sulfate prescribed last year. Patient had no known allergies. There were no concomitant medications. Historical vaccination information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot EN6203 on 26Feb2021 12:15 PM in the left arm, dose number 1, for covid-19 immunisation and the patient experienced flu-like symptoms after the first shot, and those subsided within 24 hours. Achiness, chills, sore muscles and difficulty breathing. On 20Mar2021 01:00, the patient had serious COVID 19 symptoms after the second shot that have so far lasted two days, but they seem to be abating somewhat. These were as bad, if not worse from, when he had COVID-19 in Mar2020. He had serious trouble breathing and wheezing with every breathe. He used the rescue inhaler albuterol sulfate. It didn't do much good. He sat on the couch just to be able to breathe. He thought that he was going to have to call #. After 6 doses over a 5 hour span he was able to breathe a bit better. During this time, he also had severe body aches, sever chills, mild fever, and cold sweats. Outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

1) Within 4 hrs of injection #2, highly fatigued, took two hours nap; 2) evening of Day 1, mild headache. Day 2: mild fatigue, no headache, mild lymph node swelling in neck. Night of Day 2: woken from sleep by nasal congestion, moderate airway constriction, wheezing. Cleared by next morning without need for rescue inhaler . Day 3: continued mild fatigue

4/4/21 woke up more tired than usual. Progressed from there, prominent fatigue for the next couple days, slept on the couch on and off for a couple days which was unusual for him. Mild SOA and weakness 4/7/21. Died in his sleep into the morning of 4/8/21.

Started to experience pins & needles feeling in my chest which spread to my extremities. Then had trouble breathing and felt tightness in my throat. Lasted about 5 to 6 min.

I was going up and down a ladder while painting the eves. I bent over trying to catch my breath with my hands on my knees.My wife who is a nurse said that'snot normal and we need to go to the hospital. While driving there I felt a tingling in my entire body and thought I was going to pass out. We got to the hospital and they hooked me up to a monitor. My heart beats were super low and jumping all over the place throwing PVC's. It showed my rate going down to 28 beats and then back up to 60 and down again.It was all over the board. They decided to keep me overnight for observation and tests. Saturday night they drew blood twice to run tests and took urine samples. Here is the list of tests, doctor and dates: NM STRESS TEST 1/2 (RADIOLOGY) , MD Apr 12, 2021 Imaging NM STRESS TEST 2/2 (CARDIOLOGY) , MD Apr 12, 2021 Imaging ECHOCARDIOGRAM 2D COMPLETE W OR WO CONTRAST PRN , DO Apr 11, 2021 The result is abnormalLab LIPID PANEL , DO Apr 11, 2021 Lab CBC , DO Apr 11, 2021 Lab MAGNESIUM , DO Apr 11, 2021 The result is abnormalLab BASIC METABOLIC PANEL , DO Apr 11, 2021 Lab TROPONIN I , DO Apr 11, 2021 Lab TSH , DO Apr 11, 2021 The result is abnormalLab HEPATIC FUNCTION PANEL , DO Apr 10, 2021 Lab URINALYSIS AUTO ONLY , DO Apr 10, 2021 Lab URINALYSIS REFLEX TO MICROSCOPIC-INPATIENT , DO Apr 10, 2021 The result is abnormal Lab D-DIMER,QUANTITATIVE , MD Apr 10, 2021 Imaging XR CHEST 1 VIEW AP PORTABLE , MD Apr 10, 2021 Lab CBC WITH DIFFERENTIAL , MD Apr 10, 2021 The result is abnormalLab BASIC METABOLIC PANEL , MD Apr 10, 2021 Lab TROPONIN I , MD Apr 10, 2021 Lab MAGNESIUM , MD Apr 10, 2021 The result is abnormalLab BNP PRO , MD Apr 10, 2021 Lab CBC WITH DIFFERENTIAL REFLEX MANUAL DIFF , MD Apr 10, 2021 Other type of result ECG 12-LEAD , MD Apr 10, 2021 Results are that they did not find anything really out of whack to cause the symptoms.My heart beats jumped up to 190 and they put me on beta blockers for now.

03/07-27 Progressive left and right hip pain 03/13-03/14 and 03/20 Significant hip pain after yard work 03/07-03/27 Progressive left and right groin pain 03/13-03/14 and 03/20 Significant groin pain after yard work 03/07-03/27 Progressive outside lower right calf pain (sporadic) 03/13-03/14 and 03/20 Significant lower right calf pain after yard work 03/28 Unusual reaction at night following second vaccine - flushed 03/28 - 04/01 Progressively acutely severe both hip, groin, and lower outside calf pain 04/02-05 start of indigestion, heartburn, brain fog, fatigue, leg tremors - leg pain less with Tyleniol 04/05 Significant chest pain - went to ER - EKG, blood work, chest x-rays checked OK, given GI cocktail 04/05 - 04/18 Leg/hip/groin pain (joint and muscle) - not as severe as first 5 days after 2nd shot), some heart burn, indigestion , cotton mouth, periodic tremors, periodic fatigue, feeling of thickening throat, slight eye burn, easily chilled o Each episode is preceded with an allergic reaction type feel o Each episode is near end of 8 hr Tylenol duration although seems worse at night

Pt c/o tongue feeling swollen and difficulty breathing. Observed pt to be having dyspnea and face flushed. BP: 130/80, Pulse: 75. EMS notified. Administered Epi Autoinjector 0.3mg x 1 IM (L vastus lateralis) at 10:02. EMS arrived at 10:05 and assessed pt. Recommended to go to hospital but pt refused. Wanted to see his MD.

Female who presents to the office today stating last Thursday on 2/25/2021 she received her first Covid vaccine which was Pfizer. She reports premedicating herself before the vaccination with 1 Pepcid and 2 Benadryl. However unfortunately within 13 minutes of receiving the vaccine she started to experience a and irritation of the tongue/throat with tingling sensation followed by throat hoarseness, a cough and a red face. She was experiencing a little bit of chest tightness in addition to a little bit of shortness of breath and therefore used her albuterol inhaler. Shortly thereafter her red face improved. EMS was called to the scene however by the time they arrived she was improving and was sent home. She took a Benadryl at home later in the evening and the following day on Friday she started Pepcid daily since that time. She states since the vaccine she has felt poorly describing exhaustion and feeling achy all over with continued raw throat. She has not warranted use of her albuterol inhaler since last Thursday and ran out of Benadryl Thursday evening only utilizing Pepcid daily and continues on her other medications. She reports a history of allergies to petroleum products including polyethylene glycol which is suspected to be the cause of her allergic reaction

Shortness of breath with progressive Dyspnea. Found to have bilateral PE with right sided pulmonary infarct.

2nd shot received 2/1/2021. Shingles seen 02/18/2021. Blisters broke 02/19/2021. Visited doc 02/20/2021. Rx Valacyclovir (7 days). Pain lasted 2 weeks. Fatigue since then has caused me to have to nap almost every afternoon, 1.5-2 hours. Unable to concentrate for as long as I used to. Shortness of breath and inability to walk as far as normal (regular 1.5m walk now a challenge). Worsening tinnitus.

breathing was labored; minor sore arm; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27Jan2021 13:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma, hypertension, Immature White Blood Cells (monitored for years), heart Premature ventricular contractions, anxiety, gastrooesophageal reflux disease, drug hypersensitivity. The patient had not taken any other vaccine in four weeks, he took other medication within two weeks. The patient did not had covid-19 prior to vaccination and not tested for covid-19 post vaccination. On 27Jan2021, patient had no side effects at time of vaccination but at night of vaccination date, patient experienced minor sore arm and on the next day on 28Jan2021 at 07: 00AM breathing was labored. The patient visited to doctor or other healthcare professional office or clinic visit. The doctor put patient on Zpac and Oral Steroids as therapy for events. Outcome of events was recovering. Lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Z79.01 - Chronic anticoagulation J18.9 - Left lower lobe pneumonia R29.6 - Multiple falls A41.9 - Sepsis (CMS/HCC) R09.02 - Hypoxemia J44.1 - COPD exacerbation (CMS/HCC) I50.9 - CHF exacerbation (CMS/HCC) R79.89 - Elevated brain natriuretic peptide (BNP) level

ED to Hosp-Admission Discharged 4/16/2021 - 4/20/2021 (4 days) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Patient: Date: 4/20/2021 DOB: Admission Date: 4/16/2021 MRN: Length of stay: 4 Days PCP: Discharging provider: Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Unknown Acute on chronic renal insufficiency Yes Diabetes mellitus type 2 in nonobese (CMS/HCC) Yes Cardiomyopathy (CMS/HCC) Yes Overview Addendum 3/23/2021 10:42 AM Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Formatting of this note might be different from the original. Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Persistent atrial fibrillation (CMS/HCC) Yes Acute respiratory insufficiency Yes Hospital Course HPI: 66-year-old male admitted with COVID-19 infection on 4/15. COVID-19 infection: In setting of immunosuppressive therapy. Patient was hypoxic on admission. He was treated with remdesivir?completed 5-day course on 4/20. Was treated with convalescent plasma. Patient was weaned off oxygen during hospital stay?his saturation was 96% on room air. He was not getting desaturation on activit during his hospital stay. He will not require dexamethasone on discharge. Atrial fibrillation: Patient remained in atrial flutter?patient recent pacemaker placement done. He was having tremors in extremities and so amiodarone was decreased to 200 mg once a day after discussing with cardiology team. He will follow-up next week for device check and subsequently with electrophysiologist. He was maintained on anticoagulation for stroke prophylaxis. Hypertension: Remained stable?patient will be off clonidine. He was advised to continue with Imdur, carvedilol, nifedipine?blood pressure was ranging between 100?140s systolic. History of renal transplant?renal function remained stable. Patient was maintained on immunosuppressive therapy with CellCept and tacrolimus. Patient will discharge on 4/20?agrees with plan of care.

In February coughs after the vaccination and chest congestions took some antibiotics. The first week of march diagnosed for palmonogist called ammonia. For 20 days I had antibiotics and after that i had blood test and physical on 15 march with the primary doctor. Protein test and allergies test. The test indicated the blood levels for were high. Regpa treatment, shrug/Strauss syndrome and was admitted in the hospital in April because of the syndrome had fatigue. Heart rates test and kidneys test and kind of vascular disease and they had me on steroids. EGPI diagnosed since then.

Fever, chills, myalgia, new loss of taste and smell Sore throat and Cough Shortness of Breath Fatigue Headache Diarrhea

ED to Hosp-Admission Current 5/20/2021 - present (6 days) Last attending ? Treatment team Syncope and collapse Principal problem History of Present Illness a 66 y.o. yo male presenting to the ED with syncope. Patient is diagnosed with COVID-19. He has passed out twice today. He feels lightheaded and nauseous prior to passing out. He wakes up feeling diaphoretic. Denies chest pain. Admits to shortness of breath and the feeling of difficulty getting a deep breath in. Patient denies history of blood clots, recent unilateral leg swelling or edema, hemoptysis.

Erythema multiforme; Hives over parts of the body growing and changing shapes; itchy; painful to touch; high fever 104.5; intense night sweats; chills; cough; wheezing; fatigue; body weakness; muscle pain; headache; cannot sleep; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 19Mar2021 19:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Diabetes type 2, CAD (coronary artery disease), BPH (benign prostatic hyperplasia), osteoarthritis, gall stones. Concomitant medications included metformin; eicosapentaenoic acid ethyl ester (VASCEPA); ezetimibe (ZETIA); fenofibrate; ursodiol. The patient previously took morphine and known allergies to morphine, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 26Feb2021 18:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Covid-like symptoms (high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep) from 18Apr2021 and had a covid test (Nasal Swab) on 22Apr2021: negative. The patient also experienced hives over parts of the body growing and changing shapes, itchy, painful to touch - erythema multiforme on 29Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events and included amoxicillin sodium, clavulanate potassium (AUGMENTIN), azithromycin (Z-PACK), ibuprofen (ADVIL), paracetamol (TYLENOL), diphenhydramine hydrochloride (BENADRYL), cetirizine hydrochloride (ZYRTEC). The outcome of the events high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep was recovered on 27Apr2021, of the other events was not recovered. Information about lot/batch number has been requested.

Pt is a resident in a SNF. He went for dose 2 of his Pfizer Covid series at 950am on 6/2. At 12:30am on 6/3 he became weak, anxious, SOB and required oxygen supplementation. He was shaking and weak and transferred to hospital via ambulance.

He reported sharp pain on both sides of his ribs that radiate around the sides towards his back that is present with deep inspiration and coughing Symptoms started shortly after receiving his 2nd Covid vaccine - MD Notes The onset of his first episode of chest pain was 5 days after his first pfizer covid vaccine. His second episode of chest pain started 3 days after his second Pfizer covid vaccine Adm - 4/13-4/16 & 5/1-5/3/21

AS LISTED IN #17 , I RECEIVED A TEXT AND EMAIL FROM THE COUNTY ON THE 20TH TO REPORT FOR THE 2ND SHOT ON THE 21ST, WHICH I DID, WHICH WAS A WEEK TO SOON AND NOT 1 OF THE 4 PEOPLE WHO LOOKED AT MY VACCINE CARD TOLD ME I WAS THERE TO SOON. AND THEY PROCEEDED TO GIVE ME THE SHOT. I WAS ALSO UNAWARE THAT I WAS THERE TO SOON UNTIL THE ADVERSE AFFECTS STARTED THE NEXT DAY. THAT'S WHEN I LOOKED AT MY CARD AND NOTICED THE MISTAKE. THE ADVERSE AFFECTS WERE AS FOLLOWS: FIRST CAME SHARP STABING PAINS MOVING TO VARIOUS PARTS OF MY BODY THEN CAME COMPLETE FATIGUE WITH INTERMITTENT FEVER AND CHILLS THEN CAME STOMACH ISSUES WITH DIARREA THEN CAME SEVERE SHORTNESS OF BREATH AND SOME CHEST PAIN I AM RECOVERING SLOWLY BUT STILL FATI

Pt had first dose of Pfizer COVID vaccine on 3/9/2021 and second dose on 3/31/2021. Pt tested positive for COVID-19 on 5/18/2021 and did have symptoms, such as diarrhea, myalgia, and cough/chest congestion. He presented to the ED on 6/2/2021 and was admitted for COVID-Pneumonia and afib with RVR. Pt still inpatient.

when I spit up, there was blood; couldn't breathe; tired; Caller stated he is as sick as a dog; fever; my stomach feels like push ups; first shot in Jan2021/he didn't get his second shot until 01Apr2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (at the age of 66-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on Jan2021 and experienced back injury. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose in January, and he was supposed to go back for second dose on 08Feb2021. However he was not able to attend second dose appointment and did receive second dose until 01Apr2021: yesterday morning (26May2021) he couldn't breathe he was tired and was down, he had a fever, he had 5 blankets on him. His stomach felt like push ups and he had a spit, when he spit up, there was blood. He was as sick as a dog. The outcome of the events was unknown. Information on the lot/batch number has been requested.

1. within a few days of second Pfizer Covid-19 injection: shortness of breath, high chest pains; went to emergency room; admitted on 3/31/2021, only finding was evidence of a previously unknown A-Fib, released 4/2. 2. returned to emergency room on 4/11/2021; found abnormally build-up of fluid in pericardial lining of heart; diagnosis was acute pericardial effusion; emergency surgery required to drain fluid; insertion of discharged 4/16/2021 3. returned to emergency room on 4/30/2021 with same symptoms as earlier; no additional fluid found around heart, but draining led to some pleural effusion; general belief that the heart lining was still inflamed; discharged 5/3/2021

Developed symptoms of Fatigue, shortness of breath, fluid retention prominently noted around the date of May 8. Went to urgent care on May 17th and was admitted for new onset atrial flutter/fibrillation with slow heart rate in the 30's with pauses > 3 seconds. My condition was monitored via telemetry, echocardiogram, TEE, CT scan of the chest, and cardiac cath Monday PM through Thursday. I had cardio conversation on Thursday along with a pace maker placement. I was diagnosed with a pericarditis (pericardial effusion), pulmonary edema, new onset A Fib, and bradycardia.

This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration on 19Apr2021 (at the age of 66-years-old) as dose 2, single for COVID-19 immunization. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included restless legs from an unknown date. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The patient does not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included pramipexole; and amitriptyline hydrochloride (AMITRIPTYLIN) both were taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) on 22Mar2021 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization. It was reported that the patient started noticing shortness of breath 2 weeks after second vaccine (reported as 07May2021), then noted his heart rate was 120. He went to family doctor, his EKG was abnormal, then went to hospital. CT showed multiple pulmonary clots and some massive, they noted extensive clot in right leg. He was then admitted to ICU. Have no history or underlying cause for clots, no travel related. The doctors felt highly related to vaccine . The doctor stated likely to never be back to level of health before vaccine. The patient was hospitalized due to the reported events from 07May2021 to 11May2021. The reported events were considered life-threatening and disabling. Therapeutic measures were taken as a result of the reported events as the patient received blood thinners. The reported events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was recovered with sequel on an unspecified date in 2021. Since the vaccination, the patient has not been tested for COVID-19.

Starting the next morning, patient started noticing slight chest pain with deep breaths. Pain grew significantly over the next three days and mild fever began. Went to the ER and was sent home after doctor ruled out heart attack. Returned to ER the next day with significant increase in pain when breathing, especially when lying down. Fever increased significantly to 102.5. He was then admitted with a diagnosis of pericarditis and discharged two days later. He returned to the ER the day after discharge with increasing pain, ever, and breathing difficulty. CR-P was nearly 200. Diagnosed then with Cardiac Tamponade. About 500 ml of fluid was drained in an emergency procedure. He was admitted again. Over the course of the month of March, he was in the ER five times and admitted four times. He continues to suffer with thickened pericardium and is still being treated with anti-inflammatories, including ibuprofen, colchicine, and Prednisone as of June 30, 2021. Doctors are trying to taper the steroids but have had to increase the dose several times during this process as some symptoms return on tapering. CR-P has finally started to go down and is currently at 3.

The next day after vaccine, I experienced all symptoms of COVID 19 except for sore throat. I went in to see my family practice doctor, got tested for COVID 19. It came back negative. These symptoms lasted for a month. I thought I was going to die. I still have fatigue, wheezing and a cough. I have been shaky and have fallen several times. I have lost 40 pounds since I received this vaccine. My family practice sent me to a GI doctor. I have also been referred to an oncologist and cardiologist to do CT scan and figure out why I still experience fatigue. Cardiologist appt on 07/13/2021.

chest pain, sweats, nausea, diaphoretci, tachypnea, possible V2 and V3 ST elevation, pancreatitis, gastroduodenitis, elevated lipase, leukocytosis, hyperlipidemia, myoclonus/twitching of face muscles

Breakthrough case after full vaccination. Per report from the prison, patient reported he felt awful and was having trouble breathing. Reports onset 9 days prior. Reports vomiting. Weight loss of 12lbs since 7/8/21. Reported diarrhea x 7 days. Reports cough and chest pain with coughing. Patient was transported to local ER via EMS.

1. After 10 minutes of Vacination, warm feelings in lower limbs. Subsided after 2 minutes or so 2. Again the same feeling came as wave in the lower limbs after a few minutes. 3. It repeated 3 or 4 times. 4. 5th time it started to my torso, the feeling of warmth and suddenly i started to breathe heavily 5. Started to sweat and had difficulty in breathing. 6. Weakness of whole body and a sort of numbess over whole body. 7. Felt very very weak. Called out for help from the nurses, We were asked to wait for 15 minutes after the injection. 8.Admitted to Short stay ward. Physician attended me but no other medication was given.(Surprisingly) 9. After more than an Hour i was discharged. But no one called to enqu

Hives, Skin turned red, and face turned red in warm, over span of 1 hour from vaccination time. Starting to have Shortness of breath and chest felt tight prior to being transported to Emergency room.

vomiting x3 1/8/21 1/9/21 00:34 - called to resident room by CNAs, staff stated resident was "different". Vitals taken and 02 sat was low, O2 in room and applied via NC @3L, O2 sat returned to 98 and all other vitals WNL including BS. Resident asked how he felt, stated he felt "okay". Resident exhibiting some shakey movements and clearing throat, states he does not have any phlegm or drainage or trouble swallowing. MD called and updated on situation, voicemail left. 1/9/21 11am- resident has been making a "growling" noise this shift. resident also has tremors. resident alert and answers questions appropriately. when asked if resident wants to go to hospital, resident firmly states "no". vitals wnl. no emesis noted. will continue to monitor resident. 1/9/21 12p- resident not answering questions appropriately. resident only answering yes or no. resident cannot tell me name, or the year, resident cannot state where he is currently or birthdate.

Resident was vaccinated on 12/31/20. Then on 1/14/21 he tested positive for SARS-CoV-2 on routine surveillance PCR testing. Another resident on the same hall was COVID positive on 1/11/21. Results of the PCR test were obtained on 1/16/21. He appeared asymptomatic at that time. Given his COVID positive status, all aerosol generating procedures had to be stopped. Overnight on 1/16/21 into 1/17/21, he had the onset of acute respiratory failure and was transported to the hospital. Per notes, he was put on BiPAP for several hours, but his CO2 level did not improve. Per prior advance directives completed with the resident and his two brothers, he had DNR/DNI orders. The hospital physician spoke with his brother and the decision was made to move to comfort care. He was discharged to inpatient hospice and died around 4pm on 1/18/21. This outcome does not appear to be vaccine-related, but death from COVID-19 infection is listed as a reportable event following COVID-19 vaccination.

Two hours post vaccination it was reported by nursing staff that patient had difficulty breathing. Pt shortly afterwards had a seizure

PATIENT WAS IN WAITING AREA AFTER THE VACCINE. HE HAD REDNESS IN HIS EYES, HAD DIFFICULTY BREATHING, RASH ON BOTH ARMS, AND WAS SLIGHTLY WARM TO TOUCH. WIFE REPORTED PATIENT HAS HISTORY OF ANXIETY ATTACKS, ASTHMA ATTACKS, AND ALLERGIC REACTIONS TO FOOD.

Isolated fever to 103.2 on 2/4 - resulted in hospitalization. He was febrile to 102 on arrival with WBC count 11.9 with a L shift, leukocytosis resolved within 2 days, no further fevers documented afte rthat. CXR with most likely atelectasis. Pt unable to provide history, staff not observing respiratory symptoms, pt on room air. Initially started on vanc/zosyn despite negative procalcitonin -> AKI -> repeat procalcitonin minimally elevated (likely due to vanc/zosyn combination), stopped antibiotics, AKI resolved and procalcitonin again normal.

Pt c/o coughing and SOB pt states he received 1st dose of covid vaccine on the 01/22/21 presented to the ED with fever, chills and shortness of breath. He tested positive for covid. In the ED he was hypoxic to 87% on RA. # Hypoxic respiratory failure: 2/2 covid pna. Room air sats 87%, up to 92% on 4L # COVID pneumonia: no suspicion for bacterial etiology. REMDESIVIR administration started on 1/25/21. Transferred to Hospital, (2/3/21) for higher level of care Intubated COVID 19.

Felt Dizzy, plus rapid heartbeat, tightening of throat, muscle soreness and fatigue. Symptoms occurred 45 minutes after injection. Symptoms lasted about 90 minutes. Did lay down for 15 minutes which helped.

Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632.

Cold/flu-like overnight 12 hours after vaccine, fading later in the day. Symptoms increased the next night, increasing each day to peak on day 8 (02/19/2021. Symptoms gradually decreased thereafter until 02/26/2021 at the time of this note. Symptoms are now very minor residual intranasal congestion and slightly more significant chest congestion. Symptom trajectory started as rhinorrehia and pronounced nasal congestion that partially responded to decongestants and improved more with nasal fluticasone. Bronchial congestion began after on day 3 to 4, with shortness of breath experienced overnight (never before experienced). Remarkable, intense aerobic exercise was done with no difficulty during the day, with some moderation taken on 02/19/2021. Fatigue did affect daily activities, but not dramatically. That this was a vaccine side effect signal is clear to me.

DEATH Narrative: Pt he reports he developed chills SOB body aches the same night as receiving the COVID vaccine on 1.26.2021-pt is currently reporting CheSt tightness and SOB Admitted to hosp: ICU with Bilateral Pulmonary Emboli, LLE DVT, NSTEMI, Arrhythmia.

evening of vaccination developed fatigue, sweats, palpitations and subsequent DOE and orthopnea that persisted and led to hospitalization 3/7/2021 for atrial fibrillation with rapid ventricular response and acute on chronic decompensated systolic CHF.

Wednesday 3-10-2021, mild dizziness, at about 5:15AM. For about 10 seconds. Thursday 3-11-2021, dizziness that made me hold on to counter and sit in chair for about 45 seconds, about 5:20AM. At work at 2:00PM, dizziness, weakness, upset stomach, breathing hard, could not stand for fear of falling. This lasted about 45 minutes. Felt better drove from work at 3:30PM. Got home another dizzy spell that lasted about 15 minutes, no other symptoms. Got to the bed about 4:30PM, stayed in bed for about 2 hours, got up ate a lite supper and went to bed about 8:30PM. Friday 3-12-2021, felt fine all day no problems.

severe ARDS and pulmonary fibrosis; severe ARDS and pulmonary fibrosis; presented to the hospital on 26Feb with severe resp distress; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on 18Feb2021 16:00 (Lot Number: EN6203) (at 67-year-old) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Store. Medical history included Malignant neoplasm of sigmoid colon, hypertension (HTN). Concomitant medications included tamsulosin; tipiracil hydrochloride/trifluridine (LONSURF), hydrochlorothiazide/lisinopril (ZESTORETIC), docusate sodium (COLACE), hyoscyamine sulfate (LEVSIN/SL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (Lot number: AL9265) at 27Jan2021 12:30 PM, Intramuscular at right arm for covid-19 immunization. Patient received 2nd vaccine on 18Feb2021 and presented to the hospital on 26Feb2021 with severe respiratory distress. Currently intubated/paralyzed with severe Acute respiratory distress syndrome (ARDS) and pulmonary fibrosis. Unknown if any correlation, Adverse event start date was on 26Feb2021. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Adverse event treatment included: Intubation/paralytics. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A contributory role of BNT162B2 to events respiratory distress, Acute respiratory distress syndrome (ARDS) and pulmonary fibrosis cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

* Sinus congestion within 24 hours * Coughing w/ Phlegm * Shortness of breath. Just walking across room caused heavy breathing. Not normal for me * Very noisy breath when laying down. In particular on left side * Headache from poor sleep/breathing * No fever * Lasted for 2-3 weeks. * After 2 1/2 week, Dr. prescribed Prednisone. This cleared up the condition within 3 days

Trouble breathing Narrative: Patient presented to the ED 2 days after first dose of COVID vaccine with a pruritic rash as well as trouble breathing. He reported the rash which was urticarial and quite pruritic was generalized, ranging from his face over his neck and back. Initially he had little relief from diphenhydramine, but after a second dose the rash was largerly resolved. Patient denied chest tightness, wheezing, tongue or lip swelling. He did not report any GI symptoms, fevers, mild myalgias but only with a slight headache. No loss of taste or spelled sensation. The rash most prominent on the right forehead raised a suspicion of herpes zoster which could also cause a headache, but ED provider ruled this out because patient had received his herpes zoster vaccination. The rash was also not painful although bilateral and asymmetric. ED physician concluded it to be a mild reaction to the vaccine. Patient was discharged on H1 and H2 blockers (diphenhydramine and famotidine)

03/23/21: Patient presented and was admitted through ED for chest pain associated with shortness of breath which is worsening from yesterday. Patient also complains of diaphoresis. Shortness of breath worse with sitting straight up and better with lying on his side. In ER patient was found to have blood pressure 119/84 temperature 97.4 heart rate of 101 bpm saturation on 6 L and can supplement therapy via nasal cannula. PMH significant of COPD on 2 L nasal cannula at home. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

All of the following symptoms lasted for a minimum of 4 days:extreme fatigue, headache, muscle pain, chills, joint pain, fever as high as 101.8, nausea, feeling very unwell, difficulty breathing off and on. I have also been experiencing dizziness and being very unsteady on my feet which is now into its 5th day.

a 67-year-old male with past medical history hypertension, CVA on aspirin and Plavix, diabetes mellitus on Metformin who presented to ED 3?30?-30-2021 secondary to shortness of air. Patient son is at bedside and states he has had complaints of cough, chest pain and shortness of air for the past 3 to 4 days. He has associated subjective fevers at home. Patient son states that his daughter checks the patient's blood sugar daily. He has not missed any of his medications or had a change in medications. His blood sugar was checked this morning and noted to be high and he thus presented to ED for further evaluation. Patient was ill-appearing on arrival to ED with respirations in the 30's as well as tachycardia and mild hypoxia. He was placed on 2 L with O2 stats stable. He states he has some relief with IV fluids but continues to have chest pain and shortness of air. He is tachypneic with Kussmaul respirations noted. Pertinent ED labs: Elevated lactic 3.0, potassium 6.8, glucose 760, BUN 33, creatinine 1.8, WBC 16, D-dimer 2636, decreased GFR 38, sodium 124, bicarb 5 VBG with pH 6.97, CO2 25, bicarb 6 Patient started on insulin drip, 2 L IV fluids, IV antibiotics, calcium in ED.

loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.

Patient took the Pfizer Corona Virus shot does 1 on march 1, 2021. He passed away on march 20, 2021. Reported being fatigued and exhausted after taking does 1. Was sleeping up 10 hours a day. On the day he passed, he reported being light-headed and struggling to breath. The paramedics worked on him for 40 minutes to try and revive him.

DEATH Narrative: 66 yo male with PMH of HTN, HFpEF, COPD, T2DM, CKD, tobacco use disorder and bipolar disorder was found dead in his home on 2/16/2021 after police did a wellness check per request of patient's sister. Patient received the covid19 vaccine (Pfizer) on 2/9/2021, vaccine was administered without complications. No prior positive for covid19. After patient received his covid19 vaccine, he was seen at same day access for increased SOB/DOE, worsened orthopnea. Per progress notes, at this last appt, patient had expressed a number of medications which he was not willing to take, attributing his worsened health to their effects. Pt has continued spironolactone despite being advised to stop it by his medical provider. At the time of visit, provider noted that this kidney function was declining (patient does have CKD). Provider discussed the importance of medication adherence and patient was started on torsemide. Hctz was discontinued, minoxidil was increased due to patient preference. Prior to this same day access/express care visit, patient was hospitalized from 1/26 through 1/28/2021 for hypertensive urgency (211/105) and that at that time, pt already had orthopnea, SOB, and dyspnea. Patient was also admitted from 1/7 to 1/8 and left AMA. While inpatient, his MRI revealed a pontine lacunar infarct that was found to be chronic. It was recommended that patient be treated with aspirin/plavix for 21 days then aspirin alone but patient declined.

Pt stated he felt short of breath, shaky and had a fast heart rate at about 1 minute after the vaccine was administered. Initial blood pressure was 168/108 with a HR of 112, lung sounds were clear in all fields. Pt was laid down on a stretcher and assessed immediately after the incident. Subsequent vitals were BP 148/94, HR 108, LS clear. Before leaving pt stated he felt better. Advised to seek emergency medical treatment if symptoms returned or worsened. Pt's wife drove him home.

Patient had onset of chest tightness 8 minutes after vaccine. Felt kind of short of breath. He admits anxiety. he was not observed to be short of breath by nursing personnel. This resolved spontaneously after 10 minutes. Blood pressure was 166/82 pulse 71, resp 20 and pulse ox 97%.

Two days after shot woke up with sunburn like rash on face and back. Was short of breath and dizzy. The rash looked like little blisters on top of bumps on my face, with red rash looking spots on back, legs, and chest. The skin on my face started pealing on my face and it burned and itched. Went to see my Pulmonary Doctor first, than Infectious Disease Doctor than Primary Care. I was treated with steroids, creams and inhalers. Symptoms would get better than repeat for the first month. Still not feeling like I am ok. Have two more doctors appts. coming up.

12:18 pulse 80 client taken to lay down on the cot. C/O rapid pulse and shortness of breath. Had patient lay down pulse88 1220 150/82 heart rate 80 1225 b/p 148/78 pulse78 1227 patient sitting up water given 12:38 b/p 130/82 respirations 12 pulse 80 patient states no further problems. Was informed to seek medical attention with further problems. Also given V-safe paper to contact for further follow up.

On 3/29/21 at 11:00pm my dad began having chills and uncontrollable shaking. My mother contacted Pfizer who instructed us to alternate Tylenol and Motrin. Tylenol given and Motrin given 4 hours later as instructed by Pfizer. On 3/30/21 around 11:10am my dad was found unresponsive, not breathing and did not have a pulse. My mother immediately called 911 and my aunt began CPR. When EMS arrived he was found to be in cardiac arrest and after 25 min of efforts by EMS my father passed away less than 24 hours after receiving his 2nd covid vaccine.

COVID Infection breakthrough in fully vaccinated individual. Patient was vaccinated on 1/30/2021 and 2/20/2021. He developed symptoms of COVID on 4/6/2021 (including fever, stomach ache, chills, nausea, cough, shortness of breath, lightheaded and chest tightness). He presented to the emergency department on 4/7/2021 and has been admitted since then on a medical surgical unit. His maximum oxygenation needs have been 3L.

At approximately 10 minutes after receiving vaccination, patient reported difficulty breathing and felt like his throat was closing up. He became visibly anxious and sat on the floor in a tripod position. Patient was immediately assessed by medical personnel. Pt remained Alert and oriented x 3, PERRL, mouth and throat assessed without evidence of tongue, throat, or uvula swelling, patient tolerating oral secretions well, lungs CTA, resp with ease; no increased work of breathing. BP 158/82, pulse 80, Resp 18, FSBS 204, SaO2 97% RA. Pt had spontaneous improvement after 5 minutes with complete resolution of symptoms. Pt declined to be transported by EMS for further evaluation at local emergency department. Pt left facility accompanied by wife in stable condition after additional 30 minute observation and complete resolution of symptoms.

3 days after first shot (given 2/19/21) I started having heart palpitations and shortness of breath. They went away in 3 more days. 3 days after second dose (given 3/12/21) I started having heart palpitations and shortness of breath again. Went to GP and diagonosed with A Fib. Went to cardiologist who confirmed A fib. Cardiologist said I was the second patient that day presenting with A Fib following a dose of Pfizer. Now after 5 weeks I am getting slowly better but still have some A fib.

I ended up with shortness of breath beginning on April 9, 2021. It got worse over the weekend and saw my PCP at 2pm on Monday April 12. They sent me to the emergency room

respiratory distress; feels crummy; Severe Heartburn, like it was attacking him; joint pain/Joint Pain, every joint in his body ached, hasn't felt pain his bad in twelve years; hands hurt; a spot on his back hurting; hurt to breathe and progressed into congestion in his lungs, that he hasn't had. States he gets an exudate up; hurt to breathe and progressed into congestion in his lungs, that he hasn't had. States he gets an exudate up; I was spitting up blood; Frequent Bowel Movements and GI Issues; GI distress; Uncontrollable Chills; Vomiting blood; Couldn't Eat for 7 Days; This is a spontaneous report from a contactable other hcp (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 67-year-old ,on 25Jan2021, as SINGLE DOSE for covid-19 immunisation. Medical history included knee operation, hip surgery, throat surgery, and foot operation. The patient has a respiratory issue and had paralyzed vocal chords and lost his voice for four years so stuff drops into his lungs and when he wakes up he has to clear crap out and reflux. Concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect was none. Prior vaccination within 4 weeks was reported as none. The patient called the doctors office on 31Mar2021 because he had an antibody test done on 30Mar2021 and he doesnt have any antibodies. The patient was very sick for eight days after the first dose. Stated it has stripped his lungs and intestinal tract. The patient got the vaccine on 25Jan2021 and he stopped being able to eat the following night (26Jan2021), then about 30 hours after, he couldnt keep anything down, the patient woke up 5:00a.m. on 27Jan2021 vomiting bright red blood for 1.5 hours and was spitting up blood. The patient has vomited a lot in his life, but never blood before. On 27Jan2021, the patient GI issues further reported as frequent bowel movements and GI distress. The patient was on the stool every 15 minutes having a bowel movement, not diarrhea, but a bowel movement. On 28Jan2021, it hurt to breathe and felt like when there is a frost outside and you breathe in and it hurts, that is how his lungs felt and how they hurt for a second and they felt that way for 5 days and it has progressed into congestion in his lungs, that he hasnt had. The patient gets an exudate up. The patient couldnt eat anything but Jell-O and liquids for 7 days, it just didnt feel right. On day 8, he started to be able to eat again but since then, 25Jan2021, he is still having trouble regulating his gastrointestinal tract. Stated if he eats, then five minutes later he has to go the bathroom but cant. On 30Jan2021 he couldnt eat, they went to a restaurant and he took one spoonful, that was it. It was 02-03Feb2021 when he started feeling like he could try food again. His digestive system is not working smoothly. He also had severe heartburn on 29Jan2021 and nothing took care of it, it was like it was attacking him. He wants to eat now but his lower GI system feels terrible. He had a big meal last night but it seems to come and go and then he feels crummy on an unspecified date. Stated it improved on 02Feb2021 but it is still ongoing. The patient stated that every joint in his body ached on 29Jan2021 described as hands and wrists still hurt, his knee is hurting, and he has a spot on his back hurting that he doesnt remember hurting before. He has had knee, hip, throat and foot surgeries and a broken back four times and he hasnt felt pain like that in twelve years. It felt like his back was broken again. He had uncontrollable chills on 27Jan2021, but never got fever. He couldnt do anything and was under 3-4 blankets. Some of his issues are intermittent, stated he just had 2 really bad days. Clarifies that he had no fever, no diarrhea and he got tested for Covid in Mar2021 and it was negative. The patient also experienced respiratory distress on an unspecified date. Treatment: States he has reflux and takes medication for it and he was chewing antacids way more than he shouldve and taking Pepto-Bismol, Prevacid, Gaviscon and nothing worked or touched. He did these treatments for his GI issues and they didnt work. The events did not require emergency room or physician office visit. The events were assessed as serious (medically significant and disability). Stated he has not received the second one, he is scared to death. Outcome of Couldn't Eat, hurt to breathe and progressed into congestion in his lungs, that he hasn't had, States he gets an exudate up, was recovering; Vomiting blood and spitting up blood recovered in 2021, Uncontrollable Chills recovered on 27Jan2021; Outcome of Frequent Bowel Movements and GI Issues, feels crummy, respiratory distress, GI distress was unknown; Outcome of Heartburn, Joint Pain, hand pain, a spot on his back hurting was not recovered. Information on the lot/batch number has been requested.

Pneumonia , walking Pneumonia. Dr. gave me Azithromycin Tablets250mg. for 5 days. I herd weazing from my lungs while breathing when i was in bed. I had a regular check up with my doctor and told him and he sent me for an X-Ray.. Thats when they said it was Pneumonia.

He woke up panicked; Vision loss; Visual disturbances; Difficulty breathing; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 31Mar2021 as a single dose for COVID-19 immunization. Medical history included: heart attack a few years ago and takes maintenance drugs for the heart condition and asthmatic and takes medication but the medications come and go depending on how he is physically. Concomitant medications were not reported. This case was from the same reporter; this case is for the husband. On 2Apr2021 he experienced difficulty breathing and they did not know if it was attributed to the vaccine but he did not have any breathing issues until he got the vaccine but it was a general feeling of something was different but did not think it was severe until the vision thing. Reporter stated there is no medication her husband takes that is related directly to the episode he experienced. On 5Apr2021, he woke up from being asleep, asked if the TV was on (which it was) because he could hear it, but could not see it. His symptoms have also resolved. He had no history of anything like that happening previously with the first dose pfizer covid vaccine. Hi wife stated that he experienced visual disturbances since then, with no prior history of vision impairment. The outcome of the events could not see, Visual disturbances was recovered; the outcome of Difficulty breathing was not recovered; the outcome of the event He woke up panicked was unknown. Information on the lot/batch number has been requested.

PULMONARY EMBOLISM Patient reported to OSH 24 days after second Pfizer COVID-19 Vaccine with SOB--diagnosed with bilateral PE/DVT and remained inpatient for approximately 3 days. Patient also diagnosed with Afib and new onset CHF during admission. Discharged home with anticoagulation.

Thrombocytopenia; He had clot in the legs and in the lungs; He had clot in the legs and in the lungs; Low platelet count; This is a spontaneous report from a contactable Other-HCP. A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 67 years). Medical history included diabetes. Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]); colecalciferol (VITAMIN D [COLECALCIFEROL]); lisinopril; insulin taken for diabetes mellitus. The patient experienced thrombocytopenia, he had clot in the legs and in the lungs and have a low platelet count on an unspecified date. The patient was hospitalized for the events on an unspecified date. The patient underwent lab tests and procedures which included CBC: unknown result on 08Apr2021, Heparin associate antibody: unknown result, comprehensive metabolic panel (CMP): unknown result and platelet count: low on an unspecified date. Therapeutic measures were taken as a result of thrombosis included Heparin drip and Argatroban. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The reported events are considered unrelated to BNT162B2 vaccine, being rather intercurrent occurrences. Clots in the legs and in the lungs were likely favored by the mentioned diabetes and by a possible hyperlipidemia (the patient was taking atorvastatin) in a setting of possible arterial hypertension (the patient was taking lisinopril). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

ECHO FEB 8, 2021; EF 55%. REREAD AGAIN IN APRIL AND EF 55% CONFIRMED. ON MARCH 5, HE PRESENTED WITH A 5 DAY HX OF SOBOE, ORTHOPNEA AND SEVERE PRECORDIAL CHEST PAIN. HE DESCRIBED THE ONSET AS SUDDEN, ABRUPT AND SO SEVERE THAT HE WAS UNABLE TO CALL 911. THE SEVERITY OF THE CHEST PAIN DISSIPATED SOMEWHAT, BUT THE DYSPNEA AND ORTHOPNEA HAD WORSENED. HE TRIED ALBUTEROL AEROSOLS BUT THESE ONLY GAVE HIM VERY PARTIAL RELIEF. PHYSICAL EXAMINATION REVEALED A NEW CARDIAC S4, CLEAR CHEST TO AUSCULTATION BUT HE WAS UNABLE TO TAKE A DEEP INSPIRATION DUE TO TO THE PLEURITIC CHEST PAIN. HIS WEIGHT WAS UNCHANGED. NO PERIPHERAL EDEMA NOTED. EKG SHOWED RBBB, LPFB; BIFASCICULAR BLOCK. NO PREVIOUS EKG FOR COMPARISON.

Acute interstitial pneumonia with significantly elevated CRP - occurred 3 days following vaccine administration. Steroid responsive. BAL negative for expanded infectious workup. No other constitutional symptoms of note.

He got his vaccine, he sat down for 20 minutes, he felt OK, went to his car and sat in his car and started feeling dizzy headed. He felt like a panic attack, and felt uneasy driving. He got home and sat for a while and noticed that his body was getting sore, and felt like he had the COVID virus and felt fatigued, joint pain that was worsening. He did not have a fever and then had diarrhea and vomiting that lasted for a week. He called an center after he talked to his doctor the first time, and they told him that he had to hang in there as 20-25% of their patient's were from the vaccine and that it would go away in a couple of weeks or so. He possibly was exposed to COVID from somebody working in his house. He took Ibuprofen for pain and soreness. He is still having the fatigue and brain fog and sometimes can't get his words together. He works part-time and is not able to do so at this point as a substitute teacher. The symptoms are getting better, but he is still not back to his normal self. He has lost a lot of coordination at this time, was an athlete and gets out of breathe walking 50 yards to his mailbox.

Topic: Acute Illness >> Mar 15, 2021 8:16 AM Reporter wrote: PCP Does the pt have current symptoms of illness? Yes Date symptoms started: over the weekend 1. Does the patient have a fever (subjective or confirmed)? Yes, between 100 and 100.6 2. Does the patient have a new onset of cough? Yes 3. Does the patient have a new onset of shortness of breath? No 4. Additional symptoms: body aches, fatigue The pt received the first dose of the COVID-19 vaccine on 3/6/2021. The pt inquired whether the pt's wife should also be tested. The pt's wife is a pt of the practice. The pt's wife only has a slight cough. The pt is currently receiving treatments for prostate cancer.

Pt arrived to observation complaining of "a little short of breath" and "a little dizzy". VS within normal limits. EMS contacted and pt. cleared by EMS.

4/1/2021 odd tickling cough, brief. Biked anyway, 60 min hard ride. But just in case started 81mg ASA qd. 4/2 odd tickling cough brief. Biked anyway, 60 min, good hard ride. not feeling ill, no fever, cough did not continue, not productive, no URI symptoms. Cough was different. 4/3 woke with pain upon taking a deep breath HR in high 40's (normal 60 +-) Like the pain of breathing after aspirating a lot of pool water. This pain was only on deep breathing; a second 'radiating?' pain was more of a constant ache in region of R scapula or supra scapular region, no tenderness to palpation. Had GB out Feb 2020.

My heart was racing and heart beat was quite rapid; I start having some labor breathing not real difficulty in breathing but just like slight asthma attack; My lungs kind of tightened up; Cough kind of lingered for while I was kind of clearing my lungs or something; It was kind of itching across my chest and under my neck; red kind of rash across my chest; It was kind of itching across my chest and under my neck; red kind of rash across my chest; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL8982) via an unspecified route of administration, on 25Jan2021 at 3:45 as a single dose (at the age of 67-year-old) for COVID-19 immunisation. The patient's medical history included Blood pressure high and Atrailfibrillation. It was reported that she was not been taking metoprolol and also she was not took at the time of vaccination. On 25Jan2021, 5 minutes after vaccination, the patient reported that her heart was racing and heart beat was quite rapid (PT: palpitations), she started experiencing some labor breathing not real difficulty in breathing, but just like slight asthma attack (PT: dyspnoea), her lungs was a kind of tightened up (PT:chest discomfort), cough kind of lingered for while and she was a kind of clearing her lungs or something (PT: cough), she also experienced a kind of itching across her chest and under her neck (PT: pruritis) and red kind of rash across her chest (PT: rash). The patient did not received any treatment. Clinical course reported includes; rapid heart about 5 minutes, after that started having some labor breathing not real difficulty in breathing but just like slight asthma attack. The patient's lungs kind of tightened up, was having the labor little bit of breathing but not seriously that concerned that much. It says patient was out of statics 4'oclock which was 15 minutes after the shots. Rapid heartbeats slowed down and got back to normal. labor breathing lasts till about 3 am in the morning and patient woke up and labor breathing was kind of gone away and was breathing back to a normal pace but also started after that leathery cough. So that cough lasted till 3PM, 6PM next day. So about 24 hours, this cough kind of lingered for while patient was kind of clearing lungs, was kind of itching across the chest and under the neck. It was quite itchy so was kind of scratching out of it. Patient was just in shower tonight, noticed had a red kind of rash across the chest. The patient was reported that she was little concerned about the second dose but she was okay to take her second dose. On 25Jan2021, the outcome of the event palpitations was recovered. On 26Jan2021, the outcome of the events dyspnoea, chest discomfort, cough was recovered. The outcome of the event pruritis was unknown. The outcome of the event rash was not recovered. Follow-up attempts are completed. No further information is expected.

Patient presented to the ED with COPD exacerbation on 4/21/2021. Patient presented to the ED and was subsequently hospitalized on 5/8/2021. These visits are within 6 weeks of receiving COVID vaccination.

shortness of breath, bronchospasm, Rash over entire body, pain and redness at injection site, muscle aches

06/09/2021 : 1205 Pt admitted with SOB, AFIB and tested poitive for Covid19. Pt being treated for Covid 19 and is being reported as breakthrough case. Pt. Vaccinated on April 12th 2021 and May 5th 2021 with Unknown Lot # and Body Site

Patient presented to the ED and was subsequently hospitalized for pneumothorax and respiratory failure within 6 weeks of receiving COVID vaccination.

Shortness of Breath. pain in back and chest area. Went to Hospital and they found multiple blood clots had formed in my lungs. Currently they are trying to determine what caused my body to form these blood clots

Have had a significant change to the way my long standing allergies manifest themselves. Since early childhood they would manifest with congestion and wheezing - typical asthmatic reaction to allergies. Now I am getting rashes and most importantly watery eyes. I have never had watery eyes except in the most severe allergenic reactions like from peanuts or shellfish (anaphylactic shock) - and only for very short periods. Now I am getting watery eyes. from even minor food and pollen allergenic reactions. While not with the frequency of the watery eyes I am also getting rashes. The watery eyes are to the point when I wake up in the morning my eyes are glued shut. I never have had these reactions before. Note: I waited several months to report this because I was hoping it was random events - the events are not random and nothing I have experienced in my 67 years before the vaccination. With the long term health problems I have I am keenly aware of my allergenic reactions. I have always had them but never before with watery eyes and occasional rashes.

swollen lymph node in the neck; swollen face and throat; swollen face and throat; arm pain; throat irritation; tightness around the top of his head; This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported himself that a 67-year-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EN6201), via an unspecified route of administration on 19Feb2021 14:00 on left arm as single dose for COVID-19 immunisation. The patient's medical history included narcolepsy and blood pressure high. Patient's medical history (including any illness at time of vaccination) was none. He got the flu vaccine in Nov1994, and 2 weeks later he got the flu, and it was the worst he has ever had. Concomitant medications were not reported. The patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EP6955) via an unspecified route of administration on 15Mar2021 at 11:30 on left arm as single dose for COVID-19 immunisation. On 07Mar2021, about a week ago, he was outside on his deck and his face was in direct sunlight, and his face started to swell up and was tightening on one side. Where his face was covered nothing happened, but the side of his face that was in the direct sunlight started to swell up and tightened. Stated that his face felt heavy around his lips where it was in the sun. He went inside, and his wife told him he was having an allergic reaction to something and to take Benadryl. He took the Benadryl and splashed ice-cold water on his face, and the swelling went down. On 14Mar2021, that Sunday, he noticed a lymph node on his shoulder by his neck on the same side where he got his vaccine, at the 5th level according to the research he did. States that it's rubbery and movable so he didn't know what it was, but it seemed to be getting larger until yesterday. On 19Feb2021, there was no pain, but he did notice a little swelling around his throat. He has a doctor's appointment on Tuesday to see his primary care doctor. Clarified that his face swelled up and tightened on 07Mar2021. He has not gone back out in direct sunlight since this happened. He only had the face swelling and tightening for that day. Once he went inside and took Benadryl and put ice on his face it went down. Clarified that he noticed the lymph node on 14Mar2021, and it was now persisting. When asked when he first noticed the swelling around his throat, he stated that he has had throat irritation and tightness around the top of his head since the day of the 1st dose which was 19 Feb 2021 at 2PM. He also had arm pain that also started that same day, and went down his arm to the wrist, and up his shoulder to his neck, but the pain only lasted 1.5 days. On the side where the lymph node was, there was some pain in his upper throat when he touches it; when they measure the muscles in the neck, it was that 1st level where the pain was; but the pain was only on the left side. There were none other relevant diagnostic and confirmatory test results for events. The outcome of the event swollen lymph node in the neck was not recovered; swollen face and throat and throat irritation was recovered while outcome of the remaining event was unknown.

Difficulty breathing which progressively got worse over a two month period. Treatment was for blood cots in lungs and heart on July 1, 2021 spending five days in ICU.

PATIENT CALLED TO INFORM OF SHORTNESS OF BREATH IN THE MIDDLE OF THE NIGHT BEGINNING A FEW DAYS POST-VACCINATION AND CONTINUING EVERY NIGHT SINCE (ABOUT 3 DAYS SO FAR). IT WAKES HIM UP IN THE MIDDLE OF THE NIGHT AROUND 2 AND 3AM EVERY NIGHT. PATIENT STATES HE DOES HAVE HIGH BLOOD PRESSURE AND EXPERIENCING SOME ANXIETY LATELY. I INFORMED HIM TO ALSO CONTACT HIS PHYSICIAN FOR FURTHER REVIEW.

Shortness of Breath onset for "awhile" per family. on exertion and when sleeping Pt is a 67y.o. male presenting to the ED with chief complaint "shortness of breath." Patient states that for the past week he's been experiencing gradually worsening shortness of breath. He states that symptoms are especially worse with exertion and while lying flat. He denies any history of MI/stent placement, asthma, COPD or heart failure. He reports he is a former smoker and quit approximately 2 years ago. He admits to a nonproductive cough. He denies any fevers, chills, sick contacts, chest pain, abdominal pain, nausea, vomiting, diarrhea, lower extremity edema. He reports that he is fully vaccinated for COVID. He has no other complaints at this time. Review of Systems Constitutional: Negative for chills and fever. HENT: Negative for rhinorrhea and sore throat. Eyes: Negative for pain and redness. Respiratory: Positive for cough and shortness of breath. Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for frequency and urgency. Musculoskeletal: Negative for back pain and neck pain. Skin: Negative for rash and wound. Neurological: Negative for weakness and headaches.

Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest

Per report on 6/28/21 patient began to suffer with acute onset pleuritic, left sided chest and shoulder pain. Was able to go for a walk but was suffering shortness of breath. CT angiogram showed bilateral pulmonary emboli with no evidence of right heart strain, or bibasilar atelectasis. Patient was initiated on a heparin drip and changed to rivaroxaban 15 mg PO BID for three weeks followed by maintenance dose of 20 mg daily on 6/30/21.

Reported progressive bilateral weakness and tenderness to bilateral upper and lower extremities, with associated LUE and LLE twitching beginning 3 days after receipt of vaccination. Also notes persistent dyspnea on exertion. Patient reports symptoms mildly improved with over the counter ibuprofen. Patient referred to neurology for further evaluation, appointment pending.

Shortness of breath/ Trouble breathing; Tightness in chest; I did have soreness in my left arm; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8734; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in arm left on 05May2021 (at the age of 67-years-old) as dose 1, single for COVID-19 immunisation. Medical history included heart attack from 2004 to an unknown date (had first heart attack in 2004, see a cardiologist regularly, every 4 month), heart disease (diagnosis date: stated as 17 years ago), blood pressure high, cholesterol, blockage in arteries, frequent urination and enlarged prostate. Concomitant medications included lisinopril taken for hypertension from 2004 to an unspecified stop date; isosorbide taken for hypertension from 2004 and ongoing; ticagrelor (BRILINTA) taken for an unspecified indication as blood thinner; rosuvastatin calcium (CRESTOR) taken for blood cholesterol, finasteride. The patient stated that he was taking Crestor because he had heart surgery in 2004 and had blockage in arteries, that was why he was taking cholesterol medication. Patient also took two other medications for frequent urination and visit urologist because patient frequently urinate large and had an enlarged prostate. On 06May2021 morning when the patient got out of the bed, he experienced shortness of breath/trouble breathing, tightness in chest and "I did have soreness in my left arm". The patient received the first COVID vaccine injection on 05May2021 night at his pharmacy. The patient called as he was having side effects. The patient was having shortness of breath, trouble breathing and tightness in my chest and he already have other illness like ongoing heart disease, really he did not think it was going to work out for him. On 06May2021, he saw his primary doctor and he told him that he had been having the breathing problems like shortness of breath and tightness in his chest, so he scheduled him for (incomplete sentence). The doctor was going to see him back in a week and told the patient to call him right away if he could get worse. The patient was schedule for the second dose on 26May2021 at 15:00 but right now it looks like the symptoms persist and he would not be able to get the second injection. If it going to cause him problem, he already have heart diseases and that could just going to cause him more problem. The patient had soreness in his left arm where he got the injection but that was not too bad that was okay. He could deal with the soreness. The patient stated that he could not have a heart attack or something. In another words, he was at high risk. He heard good things about Pfizer and Moderna but he don't think it was going to work out for him. He already had heart disease and then it causing him to have tightness in his chest and shortness of breath which was not good. The patient did not receive any treatment for the events. The primary doctor told him that if he started the problems still, he was going to give him a call. If the symptoms don't go, get worse, the symptoms right now that he was having tightness and the problems breathing was the same, it was from the morning. It had not worse. He could feel the tightness in his chest, right now he think like for him talking with them he have to get another breath. The patient further reported that if he don't get better then he would just call his doctor and the doctor could schedule an appointment for him for next Thursday. The patient asked if he decide not to take, not to continue with the second shot then did he have to notify again the Pfizer. The outcome of the event soreness in my arm was unknown and was not resolved for the rest of the events. No follow-up attempts are needed. No further information is expected.

very tried; legs felt weak; foggy; could not breath; This is a spontaneous report from a contactable consumer or other non-HCP. A 67-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 13Apr2021 08:35 AM (age at the time of vaccination 67-years-old), as a single dose for COVID-9 immunization. The patient's medical history included PAD, has had an operation on each leg; bypass on each leg, had to have a bypass on each leg; and COPD, he may have COPD as well they are still doing tests to see. The patient's concomitant medication was not reported. On 13Apr2021, the patient experienced very tried, legs felt weak, foggy, and on an unspecified date 2021, the patient experienced could not breath. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 test: he didn't have it, he was having bad coughing spells. The outcome for all the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

01/19/2021 developed chest pain, shortness of breath and fever 100.8. Went to ER and was diagnosed with acute pericarditis

Shot administered Wednesday morning. Sore arm, but not particularly bad. Thursday and Friday I was feeling a little fatigued, and took a nap (very unusual for me) Friday. That night i felt a little strange, light-headed. Saturday around 10 AM I developed a moderate headache, and then was mildly short of breath, and most concerning, a little bit of afib. My heartbeat was steady (nothing like the afib I first had about seven years ago or so), but I missed about seven or eight beats in a minute (my pulse is usually around 60). That was not regular. My wife thought I might be having a migraine (I have had about five in my life), but if so it was very mild. On her advice I had about a quart of water over a couple of hours, and both symptoms resolved. Currently fine.

Cough and shortness of breath with fever, began day after vaccination. COVID PCR negative. Required brief hospitalization for evaluation.

Patient complained of shortness of breath. Patient has a history of COPD, hypertension, and tachycardia. Patient give 3 Liters of oxygen by face mask. Vitals done every 5 minutes. Monitored patient until no further intervention needed. Patient left via wheelchair with his wife.

Three days post-vaccine, I began to experience chest pressure and slight pain in my chest--directly under each of my armpits. After 3 hours I called my primary care physician's office and they suggested I call 911 and go to the Emergency Department to be sure I was not having a heart attack. Multiple EKGs, a chest xray, and blood tests revealed that my heart was in good shape. I have continued to have very slight pressure in that area, but it is occasional and is almost gone. Even after 5 days since the vaccination, I am experiencing side effects although they have reduced in severity. Fatigue, occasional slight dizziness, occasional shortness of breath, occasional slight pain in various parts of my body.

shortness of breath/when he gets up to do anything it goes to 80; shortness of breath/when he gets up to do anything it goes to 80; feels uncomfortable; blood pressure was elevated along with his heart rate; blood pressure was elevated along with his heart rate; It was given in the upper left arm, he also has a little bruise that is still there now; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3302) via an unspecified route of administration on 19Jan2021 15:30 at single dose in the upper left arm for COVID-19 immunisation. Medical history included back disorder and is waiting for back surgery, high blood pressure, and very likely diabetic. There were no concomitant medications. The patient received the vaccine on Tuesday afternoon, didn't notice anything until Saturday. On Saturday afternoon (23Jan2021) he had a couple severe/serious episodes of shortness of breath. He has no other symptoms. It was better on Sunday and is better today but he still feels uncomfortable on Jan2021. He bought a oximeter today and while at rest he is at 94 but when he gets up to do anything it goes to 80. He doesn't know if this has anything to do with the vaccine but wants to know where the shortness of breath is coming from, if it is a side effect. The vaccine was administered on 19Jan2021. He has been very inactive and is waiting for back surgery that has been put off due COVID, the hospital delayed the surgery. He is very likely diabetic and takes one pill a day for this. He also has high blood pressure but is controlled and normal range is 120/70. It was elevated along with his heart rate (on Jan2021) with the bad breathing or shortness of breath episodes. He is trying to get surgical clearance and so he had an echocardiogram the Monday before the vaccine was given and a stress test on the Thursday prior to that. It was given in the upper left arm, he also has a little bruise that is still there now (Jan2021). It was given about 3:30pm. No treatment received. Event outcome of shortness of breath was not recovered, of others was unknown.

Patient was coded and expired Code Blue: Patient was in dialysis, after 30 minutes his sbp dropped to 60s he was given 4 albumin. Patient who was responsive before that became unresponsive, had seizure like activity, lost pulse and spontaneous breathing. HD stopped. Code called. Cpr started. A few minutes into cpr patient started to profusely bleed - gi bleed and ventilation became very hard., intubation was very difficult and ventilation hard as we suctioned large amounts of aspirated blood. Patient was eventually intubated. More than 8 doses of epi ws given, sodium bicarbonate * 2 given with continuous cpr. It was mostly PEA with one shockable rhythym. And shock delivered for vfib. patient continued to profusely bleed, og insertion was not successful and effective ventilation was very tough due to massive aspiration,. Possible variceal rupture with cpr from his cirrhosis is likely scenario. After 30 minutes of unsuccessful ventilation and acls protocol. Code was stopped.

Sunday morning 2/14/21 - Mild Diarrhea from 4 AM till noon, and middle of mild to moderate chest pain when inhaling for a couple of hours and then it went away.

Pfizer COVID-19 Vaccine EUA Pt observed at 1230 with prominent reddness to right forearm and reddness on left forearm. No SOB, CX pain, dyspnea. Nurse from Facility in for observation. Pt to stay additional 15 minutes. Nurse in at 1245 for eval and rash not as prominent. Pt transfered to convenenient care for bilateral arm rash. History of anaphylaxis. Rash is macular, not itchy, not burning, not pustular, not vesicular, not painful. Denies chills and fever, denies SOB, difficulty breathing, chest pain, throat tightness, tongue swelling. Vital signs WNL. Pt given diphenhydramine 50 mg PO x 1 and rash started to resolve. Pt monitored for 20 minutes after diphenhydramine. Pt discharged to home.

I have a blister on the side of my tongue. It feels like I bit my tongue really severely. Also, my throat has closed up a tad. It never opened up fully after my spine surgeries, and now I can't get the large vitamin down. Of course, if it's a choice between this and falling prey to Covid 19 or 20, I'm good.

Pt received 2nd Pfizer BioNTech Covid 19 EUA vaccine @1:50 pm; Pt released from Observation @2:09 pm. Approximately 2:18 pm RN called to parking lot and observed pt having difficulties. Called for EMS & crash cart. Vitals taken 2:20 BP 83/55, no respirations noted, pt unresponsive. AED attached. EMS arrived 2:22 and took over care of pt. and transported @2:40 pm to Hospital. Per wife, pt has history of PE in Oct. 2020, HTN, diabetes with insulin pump, obesity, gastroparesis, home oxygen and uses motorized scooter. Wife also said pt had allergy to iodine not previously reported, and MD had stopped Zarelto subsequent to 1st Pfizer vaccine 2/8/21 "due to breathing difficulty". Patient was unable to be resuscitated. Time of death 14:59.

Patient began to feel short of breath then progressed to shaking and had a seizure. 10mg Versed was administered at the clinic. Once EMS arrived another 5mg of Versed was administered.

Shortly after 1st dose (within 1 week), I developed shortness of breath. At first, it was intermittent, then as time progressed it became more "permenant". I received the 2nd dose on february 23rd while still experiencing daily shortness of breath. Occasionally experienced loss of taste but that went away. I went to my doctor & he took chest X-Ray. Showed partial "collapse" (right lung not functioning properly) of right lung. My doctor suggested "deep breathing excersizes" to re-expand portion of lung affected by side effect. I need to have additional X-Ray in 2 weeks (March 19th, 2021).

Approx 7 hrs after administration experienced rapid heartbeat, shortness of breath. Resulted in discharge of ICD device. Started O2 @ 1ltr. Called my cardiologist office responding doctor advised rest as heart rate settled 90-100 BPM. Debriefed by device lab next AM, by then heat rate had returned to normal for me.

Chest and Shoulder pain, shortness of breath, extreme pain when inhaling, Pulmonary Embolism diagnosed at hospital after ct scan and blood tests showed several lung infarctions, given xarelto for 6 months and follow up with gp. and tylenol for pain

Presented to ED on 3/15/21 with shortness of breath, body aches, chills, fever, cough, and diarrhea. Was started on supplemental oxygen and admitted to hospital for 4 days.

patient admitted to hospital on 3/7/2021 with hypotension and severe covid infection, requiring high flow oxygen therapy at 15L/min and pressors. Received remdesivir and dexamethasone and treated for bacterial pnumonia

still felt bad along with shortness of breath; received his first vaccine dose yesterday and began feeling unwell; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date were not reported) via intramuscular route of administration as a single dose in Arm Right on 31Jan2021 13:00 for covid-19 immunization. Medical history included Allergies to medications: Ace inhibitors, HHT(Hereditary hemorrhagic telangiectasia )/High Blood Pressure, Eye conditions, Parkinson's Disease. No other vaccines received within 4 weeks prior to the COVID. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination: Men's Multivitamins, Amlodipine, Tamsulosin, ferosul Iron, Ropinirole, Stool Softener. On 31-JAN-2021 21:00 the patient began feeling unwell. On 01-FEB-2021 08:00 still felt bad along with shortness of breath. No treatment received for the adverse event. Outcome of events at the time of last observation was not recovered/not resolved. Information on the Lot/Batch number has been requested.

Shortness of breath; headache; Felt like at least 100 degree temp/slight fever; lack of appetite/completely lost appetite/No appetite; Body aches; Joint aches; Tiredness; Delirious; Chills; cold sweats; felt weak; flu-like symptoms; feel almost as miserable; can't taste food as well/lack of taste; diarrhea; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration, administered in the right arm on 16Mar2021 at 10:20 as a single dose for covid-19 immunization. The patient's medical history included deep vein thrombosis (DVT) in from 2017 to 2017. Patient always had swelling on the leg where he got the blood clot. The patient's veins in his leg were damaged and the doctor takes care of his legs. He has very poor blood flow in the affected leg, that all the fluids and waters, the heart was having a hard time pumping it back up. He uses compression stockings, physical therapy, and that he raises his legs in the evening. The caller mentioned that vessels in his affected leg are damaged for good. Patient was in a treatment facility for alcoholism. Patient reported that he hasn't had a drink in 2-3 years but still has to go to treatment, caller was released from the treatment facility because he got sick with COVID. Patient had Covid-19 on 15Dec2020 to 08Jan2021 (the side effects experienced after the first dose of the Covid-19 vaccine weren't as severe, that the real virus is pretty bad). Concomitant medications included blood thinners (unspecified) and a couple of other medications. Patient reported that he skipped some doses of his regular medications while he was feeling poorly. On 16Mar2021, the patient experienced delirious, chills, tiredness, body aches, joint aches, cold sweats, felt weak and flu-like symptoms. On 17Mar2021 patient had headache, felt like at least 100 degree temp/slight fever, lack of appetite/completely lost appetite/no appetite; can't taste food as well/lack of taste and diarrhea in Mar2021; and shortness of breath on an unspecified date. It was further reported that the adverse events that he was experiencing were as bad as his experience with COVID-19 except he could breathe. Gradually over the next 24 hours and the night of 16Mar2021, he started getting chills and fevers, getting very tired, and experiencing flu-like symptoms. He had fatigue, cold sweats, slight fever, headache, diarrhea, and the lack of taste or appetite. He said that his adverse events started 10 hours after getting vaccinated. For the next few days, he felt weak and had to exert a big effort to get out of bed. On the second day of vaccination, he developed diarrhea and completely lost appetite. Patient also reported that he experienced body aches. He experienced body aches and joint aches. Patient had no appetite, that he still hasn't eaten much the last few days but that he has started eating today. He described his experience to be severe but not severe enough for him to be hospitalized. He said that he missed 3 days of work because of his symptoms. It was on the 6th day since he got vaccinated and everything has subsided and he was getting his energy back but he is still recovering. Patient called his physician and the nurse he spoke with stated that the first 3 days following the Covid-19 vaccine the side effects could be very severe and that the side effects could continue over next 3 days. Caller reported that he is on the 6th day now since he got vaccinated and everything has subsided as he was starting to feel better, he was coming around, but it was not 100 percent. So patient was inquiring about the second dose of the product. The patient further mentioned that the side effects following the first dose of the Covid-19 vaccine caused him to feel almost as miserable as he did when he actually had Covid. Patient also stated that he was close to calling ambulance the night of 16Mar2021 when he began experiencing AEs. The patient was delirious, he wasn't sure what was going on, that he was trying to grab his phone and text but couldn't use his phone. Patient was wandering around his room. Patient would get cold sweats at night. Caller reported on the morning of 17Mar2021, he woke up soaked in sweat. Patient called his doctor's office that he just needs guidance on whether or not to get the second dose. The headache went away gradually and was gone probably late Saturday, 20Mar2021 or Sunday, 21Mar2021. for the event tiredness, patient stated that he's still trying to regain his full strength but, 22Mar2021 was the first day that he has been able to sit up and do things and that he hasn't had to lay down all day long. Felt like at least 100 temp, patient reported that he doesn't have a thermostat. He reported that he felt feverish at least the first 3 days following the first dose of the Covid-19 vaccine on 16Mar2021. Body aches/joint aches, reported that the body aches and joint aches have almost completely subsided. Patient stated that he doesn't really feel them, that he is 68 and at that age you're going to feel some aches regardless if you're sick or not. Caller reported that he can barely talk, that he still doesn't feel completely right. No appetite: caller reported that when his symptoms were severe that he did not want to eat. Caller reported that he did hydrate. The decreased appetite has improved but that's still not quite what it was. Caller reported that he was trying to eat to improve his energy level. Can't taste food as well, mentioned as that everything tastes the same, whether he eats a grape or a banana. Caller reported that he noticed that he wasn't able to taste food as well the third day after his symptoms began, but states it was improving. Patient reported that the diarrhea began on 18Mar2021 or 19Mar2021 and that he can't hold it too long. He ate cereal in the morning and immediately had to use the bathroom and it's getting a little better. Patient reported that he took 1000 mg of Tylenol for 2 to 3 days in a row. He took two 500 mg tablets three times because of headache and chills. Patient stated that the only difference between the side effects he experienced following his first dose of the Covid-19 vaccine and having the Covid-19 virus was that he doesn't have any problems struggling to catch his breath. The patient recovered from the events chills on 20Mar2021, headache and felt like at least 100 degree temp/slight fever in Mar2021; recovering from tiredness, body aches, joint aches, can't taste food as well/lack of taste, lack of appetite/completely lost appetite/No appetite and diarrhea; not recovered from shortness of breath; and unknown outcome for all the other events.

Severe Shortness of Breath 10 days after vaccine. Discomfort in the right lower chest that radiates to the back.

68-year-old gentleman presented with dyspnea and found to have bilateral PE, right lower extremity DVT. He was started on IV heparin, Coumadin. Patient was found to have acute kidney injury and urinary retention, bilateral hydronephrosis. Foley catheter was placed, this resulted in improvement in renal function and resolution of hydronephrosis. First cath urine was bloody but subsequent urine has been clear. A CT urogram did not reveal any other abnormality of the urothelial system. Prostate is enlarged.

Patient was fully vaccinated (dose 1: 2/24, dose 2: 3/17). Patient developed body aches, fever, cough and SOB on 4/17 and presented to healthcare facility where he tested positive for SARS-CoV-2 on 4/21. In ED patient was febrile (38.8), hypoxic satting 90% on RA requiring NC, tachycardic (HR 114 bpm) and in AKI (sCr 1.2 mg/dL). Medications initiated for COVID-19 included enoxaparin and remdesivir. Patient is admitted, today is day 1 of hospitalization (4/21).

Extreme fatigue, weakness, moderate lightheadedness, persistent headache, mild nausea, intermittent low-grade fever alternating with moderate chills, increased nasal and lung congestion, persistent muscle ache. Lasted about 48 hours.

I have noticed extreme shortness of breath and stamina lately, and that I cannot function physically anywhere near my recent past without getting chest pains and exhaustion.

Patient admitted for worsening COVID 19 symptoms (fever, hypoxia, generalized weakness, chest tightness, dyspnea, nausea, and cough). Patient tested positive for COVID 19 in 4/15/. He received courses of remdesivir and dexamthasone, Noted by attending physician, suspected patient may not have mounted sufficient immune response with vaccine due to Cellcept.

102 deg F temp; shivering; abnormal general body fatigue; Atelectasis; double blood clot in left lung lower left lobe; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 17:00 (Batch/Lot number was not reported) at the age of 68-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Inclusion Body Myositis, Sjogren's syndrome and Known allergies included Penicillin, Lamisil, Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medication included unspecified other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Got up 9:30AM on 14Apr2021. Experienced abnormal general body fatigue. Began shivering at 1:00 PM and went back to bed. 102 degree F temp at 3:00 PM. Called primary care physician, who advised we go to Emergency room (ER). Got into ER about 6:00pm. Covid polymerase chin reaction (PCR) Nasal Swab test negative, full viral panel negative. Chest X-Ray showed some Atelectasis, Computerised tomogram (CAT) scan revealed double blood clot in left lung lower left lobe. Sent to Hospital at about 1:00 AM 15Apr2021. Treatment with 16ml/hr Heparin plus 5mg/day warfarin. Discharged 06:00 PM on16Apr2021. Adverse event resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Patient reported a pressure on his throat as if his throat was swelling. Patient was still able to talk and swallow so we observed him for a few minutes and asked if it was getting more difficult. His response was yes. At this time I gave the patient two 25 mg Benadryl tablets and called 911. EMS came and picked him up. Patient returned later that day and reported that the ER doctor thought he did have an allergic reaction.

Blood clots in lungs and UTI; Blood clots in lungs and UTI; This is a spontaneous report from a contactable consumer. A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 68 years) for covid-19 immunisation. Medical history was none. Known allergies was none. The patient did not have Covid prior to vaccination. No other vaccine was given in last four weeks. There were no concomitant medications. The patient experienced blood clots in lungs on 31Mar2021 with outcome of recovering and UTI (urinary tract infection) on 31Mar2021 with outcome of recovering. Adverse event blood clots in lungs and UTI resulted in Emergency room/ department or urgent care and then hospitalization for 6 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Apr2021. Therapeutic measures were taken as a result of blood clots in lungs and UTI and included blood thinner. Information about lot/batch number has been requested.

Shortly after receiving this first dose,my husband's breathing went downhill, two months later he was dead. They could not find the cause. I told them I knew the cause. It was the Covid shot! I reported it to his pulmonologist and to the hospital staff. He was stable with all other conditions until he got this shot!

COUGH, SOB ED Discharged 3/14/2021 (2 hours) Last attending ? Treatment team COVID-19 virus infection Clinical impression Shortness of Breath Chief complaint Clinical Support 3/15/2021 COVID-19 virus infection Dx Medication Infusion Reason for Visit Progress Notes (Registered Nurse) ? ? Encounter Date: 3/15/2021 ? ? Signed arrived to the ambulatory infusion site with his wife is also receiving.. Reports dry nonproductive cough, fatigue, shortness of breath, and dizziness. stated he discussed Bamlanivimab infusion and associates risks with his doctor prior to this infusion. Reports all question were answered to his satisfaction. Denies any concerns or needs at this time ED Discharged 3/15/2021 (2 hours) Last attending ? Treatment team Fatigue, unspecified type +2 more Clinical impression ED Provider Notes (Physician) ? ? Emergency Medicine Expand AllCollapse All HPI No chief complaint on file. HPI 68-year-old male history of asthma, COPD, diabetes, diastolic CHF who presents ED for evaluation of right lower back pain and midline lower lumbar pain. Diagnosed with COVID-19 yesterday. Had a few days of cough and fever with some mild shortness of breath. Last evening he tried to sit down, missed the chair and landed on the floor on his right side. Has had worsening weakness due to pain in his back. No weakness or sensory loss in his lower extremities. No bowel or bladder dysfunction. No urinary issues. No abdominal pain. He was having pain in his right ribs with coughing, seen in urgent care and this was negative. He had monoclonal antibody fusion this morning. He feels tired and fatigued. He did not strike his head during fall. Chest x-ray today did not show any fracture, there is no infiltrate.

Extreme fatigue, severe malaise, body aches, feeling of impending doom, shortness of breath, high heart rate, high blood pressure.

Weakness; difficult breathing; fatigue; Dizziness; general malaise; rapid heart rate; a sense of impending doom; This is a spontaneous report from a contactable consumer. A 68-Year-old male consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route in left arm on 04Feb2021 15.15 as SINGLE DOSE, for covid-19 immunization (age at vaccination: 68-Year-old). Medical history included Heart Failure, PAD, CAD and Fibromyalgia. Concomitant medications included alirocumab (PRALUENT), aspirin [acetylsalicylic acid, hydrocodone bitartrate, paracetamol (NORCO), perna caliculata extract (LYPRINOL), ca [calcium] and diphenhydramine hydrochloride (BENADRYL). Patient was allergic to food allergy, dairy products, sulfa drugs and soy. Patient not had Covid prior to vaccination. On 06Feb2021, the patient had weakness, difficult breathing, fatigue, dizziness, general malaise, rapid heart rate and a sense of impending doom. The events resulted in emergency room/department or urgent care. The patient has tested for covid 19, nasal swab on 06Feb2021, the test result was negative. The patient had not received any treatment for adverse events. The outcome of the events was reported as not recovered.

3/4, admitted 3 days after covid vaccine. Presented to ED with complaint of weakness, onset 1 wk ago. Endorses fatigue, leg swelling, ankle swelling, fluid retention. Last EF was 6 and "he feels like that same feeling now". On Eliquis and 4mg of Bumex 2x daily. Acute exacerbation of CHF (congestive heart failure) patient with known severe heart failure and ejection fraction of 24% presented with shortness of breath,profound edema, 11 pound weight gain. Respiratory PCR negative. IV Lasix 40 twice daily-continue with Lasix 40 p.o. twice daily at home. Metolazone 2.5 once a day as needed weight in excess of 235 pounds. Patient continues on Toprol-XL and spironolactone. Spironolactone was raised to 25 twice daily to try to help manage his potassium fluctuations.

death R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - Acute kidney failure, unspecified SHORTNESS OF BREATH LEG SWELLING ASCITES

burning at injection sit, 12 hours later 3am total body aches, trouble walking, breathing, chest pains, tingling in hands and feet

Patient presented to the ED for bradycardia and dyspnea present for one week prior to admission, he was found to have a second degree AV block. He underwent a procedure to correct atrial lead dislodging/placement of pacemaker. Patient was also started on anticoagulation therapy for a clot in lung. Discharged after 5 days inpatient.

Patient received second COVID 19 vaccine on 4/13/21 at Site. Patient tested positive for COVID on 5/16/2021. Patient had worsened short of breath on 5/25/2021 and was admitted to Medical and placed on a vent. Patient expired on 5/26/2021.

Patient presented to urgent care with shortness of breath. Patient had positive D-dimer and referred to the ER for CT. At ER visit, he reports progressive worsening shortness of breath over the past 3 to 4 weeks. Dyspnea on exertion 5/20/2021. Patient was admitted to the hospital with diagnoses of bilateral PE with small saddle embolus and left DVT (left popliteal vein occlusion). Treatment included heparin drip in the hospital with a conversion to Eliquis.

on the 20th day of receiving first shot, in the afternoon I felt tired and went to bed. later got up with chest pain and a severe breathing difficulty. Lost balance twice before checking into emergency in Hospital Had heart rate of 139 and high blood pressure at the emergency. Transferred to second hospital and released on March 29, 2021 around noon.

Cough Sore throat congestion runny nose Reactive airway disease/wheezing with paroxysmal cough Begin prednisone 20 mg 3 for 3 days 2 for 3 days 1 for 3 days

diagnosed with blood clots in the lungs; Coughing; diagnosed with pneumonia; She thinks that he had a blood clot in his leg that travelled. He was having leg pain, so he probably had a blood clot then; really, really sleeping; really bad leg pain; This is a spontaneous report from a contactable pharmacist (patient's wife). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729, initially reported as FR8729 then stated it is an E) via an unspecified route of administration on 03Apr2021 around 10:00 or 11:00 am (68-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included high blood pressure (also reported as family medical history), ongoing eurofibromatosis (Has had all of his life), varicose veins, overweight, rheumatoid arthritis. Concomitant medications included ongoing etanercept (ENBREL) for rheumatoid arthritis (Has been on a few years but does not remember how long exactly). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration at arm on 13Mar2021 (68-year-old at time of vaccination) for COVID-19 immunization. The patient previously received flu vaccines in Oct2021 (67-year-old at time of vaccination). There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on same date of the Pfizer suspect. The wife states her husband (patient) got 2 doses of the Pfizer vaccine. The middle of last month, he was complaining of really bad leg pain (from middle of May2021). He does have varicose veins and is on Enbrel and is overweight. He was really, really sleeping. She told him that he really needed to go see a doctor. The wife states she is in a rehab facility and is a pharmacist who worked at the hospital for over 34 years, mentions licenses in (states name). The wife stated she sent him to urgent care and they said he had varicose veins but had no problems with his leg. They did diagnose him with pneumonia. They sent him home on an antibiotic, Doxycycline 100mg, she didn't actually see the prescription, it was either for 7 or 10 days. He was down to one dose the day before yesterday. While he was at home, she heard him coughing (from 03Jun2021) and he couldn't stop coughing for about 5 minutes. She asked him when his follow up was and he told her not until Friday. She said he needed to see somebody so yesterday, he went to urgent care again. Three hours later they transferred him by ambulance to the hospital, he had blood clots in his lungs (from 03Jun2021). She is highly suspect of the Covid vaccine because he has never had problems like blood clots before. He was just admitted on the day before reporting (hospitalization for coughing and blood clots in the lungs from 03Jun2021 and ongoing). The wife is thinking maybe they misdiagnosed him approximately 10 days ago. She thinks that he had a blood clot in his leg that travelled. He was having leg pain, so he probably had a blood clot then, and they misdiagnosed him as pneumonia. The wife does not remember exact date but that it was in middle of May. His first trip to urgent care was 10 days before going to the hospital. Coughing started the same night, she asked him to go to the doctor Thursday morning and they sent him from urgent care to the hospital. He was admitted to the hospital and is still there now. Adverse events did not result in physician office visit; coughing and blood clots in the lungs resulted in emergency room visits; patient went to urgent care twice, second time was sent to emergency room via ambulance. Tests: They have been doing tests on him all day. They did an echocardiogram on the day of reporting (on 04Jun2021) and they are doing blood work on him. The wife does not know the results, she is a rehab facility a half a mile away. Treatment: They gave him some kind of shot. He doesn't give medication to himself. She has no idea, maybe something like Lovenox or something like that but she just doesn't know. Therapeutic measures were taken as a result of the event coughing and blood clots in the lungs and included some kind of shot; therapeutic measures were taken as a result of the event pneumonia and included antibiotic, Doxycycline. The outcome of the events was unknown. Causality assessment: The pharmacist (patient's wife) states she was highly suspect, as soon as they told him it was a blood clot in his lungs. Relatedness was assessed as related for all events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported serious events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient admitted 6/3/2021 found to be COVID-19 positive Event Description: Allergies (drug/food and reaction):__cephalosporine, clarithromycin Date of Vaccination 1 :__2/23/2021- Pfizer-Lot EN6198- uk- Left arm Date of Vaccination 2 :__3/23/2021- Pfizer ?lot EN6208- UK- right arm

This is a spontaneous report from contactable consumer (patient). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: ER8734) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing, vitamin D deficiency from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (penicillin allergy). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 23Mar2021 (Batch/Lot Number: EN6208) age at vaccination of 68-years-old, for COVID-19 immunization. Concomitant medications included fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported; finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced low platelets, congestive heart failure, atrial fibrillation and pulmonary edema all started on 24May2021. The events resulted in doctor or other healthcare professional office/clinic visit; caused/prolonged hospitalization and life threatening. The patient was in ICU and was put on iv drip for congestive heart failure, cardizem drip. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Patient called for tele-health visit on 6/28/2021 with symptoms including moderate and worsening cough, wheezing, chills, fever, stuffy nose, sore throat, body aches and pleuritic chest pain. He reported cough onset was 2 days prior and the rest of the symptoms came on over the last 2 days. Patient was tested for COVID-19 and told to follow-up if no improvement or symptoms worsen. Patient was admitted on 6/29/2021 after presenting to the ER with 3-day symptoms of aches, chills, fever (103.5 on that morning), fatigue, weakness, shortness of breath, cough and diarrhea. He was put on 2L of oxygen, IV fluids, dexamethasone, remdesivir and tocilizumab. He was then discharged on 7/3/2021 after receiving a full course of steroids and remdesivir. Patient reported back to the ER on 7/11/2021 with continued shortness of breath, weakness and diarrhea. Patient was given azithromycin and lovenox in the ED. He was readmitted and received a second course of remdesivir and tocilizumab, as well as prednisone. Patient was then discharged again on 7/21/2021.

Anaphylaxis throat itchiness, throat tightness, sinus swelling, ear fullness Narrative: Patient reported throat itchiness, throat tightness, sinus swelling, ear fullness. Transported via EMS to nearest ER

Patient said he felt like someone was holding his throat but he mentioned that he had a history of throat tightening. We gave him 2 Benadryl and checked on him about 8 times (roughly every 10 minutes or so) and he said he felt like normal. We checked on him a couple more times and he said he felt fine. We left him 2 more Benadryl just in case he needed it and we alerted the facility

Patient said he felt like someone was holding his throat and he mentioned he has a history of throat tightening. He was given two Benadryl and was checked on about 8 times (every 10 minutes or so). He said he felt like normal and was checked on 2 more times

Patient presented to waiting room after having COVID 19 vaccine #1, feeling short of breath after 5 minutes in waiting room. Color pale, skin diaphoretic. Laid patient in clinic room bed; BP 142/82 Pulse 60 (Patient avid swimmer)Pulse Oximetry 92%. O2 per nasal cannula at 2L. Patient has leukemia and received monoclonal antibodies last March. Pulse oximetry fluctuated from 92%-97% with O2 on. 911 called and report given and taken to ED per stretcher per ambulance. Patient at discharge not short of breath alert and oriented and BP 138/72-62.

Patient presented to waiting room after having COVID 19 vaccine #1, feeling short of breath after 5 minutes in waiting room. Color pale, skin diaphoretic. Laid patient in clinic room bed; BP 142/82 Pulse 60 (Patient avid swimmer)Pulse Oximetry 92%. O2 per nasal cannula at 2L. Patient has leukemia and received monoclonal antibodies last March. Pulse oximetry fluctuated from 92%-97% with O2 on. 911 called and report given and taken to ED per stretcher per ambulance Patient at discharge not short of breath alert and oriented and BP 138/72-62.

Difficulty breathing, stridor about 30 minutes after vaccine, Pt received albuterol treatment, solumedrol and benadryl IV. Pt's respiratory status improved

fever started 12/30 after vaccine and resolved. returned around 1/3/2021 with mild cough and decreased appetite and loose stools, went to ED and tested positive for SARS-CoV-2 PCR on 1/4/2021. Received bamlanivimab on 1/9/21. Symptoms worsened with worsening SOB and went to ED on 1/11/21 and was admitted. While here received remdesivir and required max O2 4 liters on nasal cannula. Discharged on 1/20/21 on home oxygen 2Liters. 2/3/21 readmitted for complaint of 3 days of persistent SOB, headache, weakness and poor appetite.

4 hours after vaccine, developed aching in joints and muscles which disappeared after 1 day. 15 days later, woke up with all the same COVID-19 symptoms he was sufferering from a few months ago: nausea, aching, feverish, sweating, chills, and brain fog. Some shortness of breath. Patient saw me a few days later feeling like he was dying. He was treated with steroids and vitamin C along with glutathione IV treatment. Started to feel better the next day. A week later, felt nearly back to normal.

Fatigue, headaches, decreased appetite, SOB, body aches about 2 days after vaccine administration that has lasted 10 days

12 hours following the injection I developed a severe anaphylactic reaction including extreme swelling of lips, tongue, soft palate; difficulty breathing when reclined; difficulty swallowing and difficulty speaking coherently. My wife called 911 and I was transported by ambulance to the ER at Hospital. While enroute I was given epinephrine and Benadryl. I was admitted to the hospital overnight for observation. On February 4th I was evaluated by an allergy specialist who ordered a RAST blood test for food allergies since I had eaten shrimp that day. Tests for all food allergies were negative.

Patient was in to receive his second dose of the COVID vaccine. He reported no known issues after his first dose and remained in the pharmacy for the recommended 15 minute observation period following the vaccine without any problems. He reported to us today that around 45 minutes after having received the vaccine, he started to have a choking episode, something that he commonly experiences with his Parkinson's Disease, so he and his wife didn't think much of it. This seemed to evolve into nausea and dry heaves with excess mucus production that lasted for hours. Because of the duration, they decided to contact his insurance company's nurse line who recommended he go to the Emergency Department to rule out COVID and pneumonia He was admitted to the ED and ultimately found to be negative for both COVID and pneumonia, at which point they decided that his Parkinson's exacerbation might have been the result of having received the vaccine. He has since been discharged and is doing well.

The patient is a 69 y.o. male with a past medical history notable for atrial fibrillation, CHF, COPD, history of GI bleed, coronary artery disease. The patient presents for evaluation of worsening issues with nose bleeds and shortness of breath. Patient is found in the ER to have a significant nose bleed which required packing. Patient was also found to be in atrial fibrillation. Patient was previously at skilled care facility undergoing care and it is unclear patient had been using illicit substances. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

Symptoms: Light headedness, slight queeziness in stomach, raised blood pressure, tightening of throat, some difficulty breathing. Treatment: 30 minute retention in observation area, lying in cot in EMS area for 20 minutes, water to drink Duration; Lightheadedness and tightening in throat lasted about 3 hours in total though symptoms did decrease over time.

Patient received his second COVID pfizer vaccine on 2/27 and 10:30 AM. Several hours after receiving the vaccine pt become more lethargic with increased AMS and reached a fever of 103 and came to the emergency room on 2/28 around 3 AM. Pt had a prolonged course of COVID in May 2020. All other infections ruled out and pt now stable. However this is believed to be febril illness post-COVID vaccination

Patient received dose #1 of Pfizer's COVID-19 vaccine at 12:12 PM. While waiting in the observation area, he experienced left-sided chest pain. C/o of some SOB and diaphoresis. Reports cardiac history. Felt somewhat clammy. Placing hand over left chest area. VSS. First Responder called with prompt response. Immediately transferred in to ED with assist of RN at 12:30 PM.

Evening of vaccine administration and still ongoing 2 weeks later - headache, chills, fatigue, achy, SOB on exertion, occasional tremors, dry cough which has subsided considerably. 1 1/2 weeks out hives again covering entire body and not subsiding with 50 mg Benadryl every 6 hours. 2 weeks - sore throat and swollen glands

on 2/28/2021 woke with sore arm, chills,.shortness of breathe, mild body aches all were gone by2/30/2021. on 3/07/2021 experience shortness of breathe, chills and a lot of stomach and intestinal gas also hard a rash on left shin area these were gone by 3/08/2021 except for rash on shin which is slowly going away.

Progressively worsening difficulty breathing, culminating in collapse and NEAR DEATH, on 14/03/2021. Results from the E.R.: extreme hypertension and fluid in lungs. Intubated (breathing) for a day. In E.R. for at least 2 days.

Acute respiratory failure (CMS/HCC) CHF (congestive heart failure) (CMS/HCC) Renal insufficiency NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pneumonia due to COVID-19 virus Covid-19

Congestion in chest and sinuses, some swelling of throat and tongue. Had taken Prednisone and Benadryl an hour before the injection. Took an additional 25 mg. Benadryl about 90 minutes after the injection. This was the second injection. A worse reaction, with noticeable swelling of throat and tongue, as well as difficulty breathing, after the first injection on March 1. Only Benadryl, and not Prednisone, was taken on that occasion.

admitted to the ICU with acute respiratory failure. h/o DM and HL, prior h/o smoking and EtOH and opium abuse (none x 28 yrs, per family). Received second dose of the Pfizer COVID vaccine in AM of 3/16, having had severe adverse reactions (fever up to 104, n/v) to the first dose three weeks earlier. Experienced recurrent fevers (up to 103) beginning by the evening of 3/16, for which he took acetaminophen. Awoke at 3 AM w/ recurrent fevers, for which he took ibuprofen. Felt better in AM, had breakfast, and retired back to bed. Awoke shortly after noon w/ severe n/v and AMS. Was brought to the ED by the EMS. Febrile (T 39.6) w/ rigors, tachycardic, tachypneic, and poorly responsive on arrival. Continued to experience episodes of emesis, and was felt to have possibly had a seizure episode ("looked to the side and was shaking"; no clear tonic-clonic movements noted). Was thus intubated for airway protection. Initial laboratory w/u revealed presence of mild leukocytosis (WBC 12.6, 47p49L0Eo), lactic acidosis (LA 5.2), hyperglycemia (glu 297), elevated lipase level (161) renal insufficiency (Cr 1.23). extubated on 3/19. received antibiotics for positive blood culture (streptococcus parasanguinis). diagnosis: ADVERSE EFFECT OF CORONAVIRUS COVID-19 VACCINE

Patient is a 69 y.o. male patient who originally presented to the hospital on 3/23/2021 due to shortness of breath. Patient had 1 week of shortness of breath. He starts experiencing 2 weeks of pain in edema right lower extremity. Did notice increasing dyspnea on exertion. Was noted to have bilateral PEs with evidence of RV strain on CT scan. She admitted to the ICU on heparin drip he did undergo tPA. Echocardiogram documented to be improving. Patient now baseline ambulatory in the room without oxygen stable.

Hyperventilation, tachycardia, Shortness of breath, hypoxia. Pt was treated prior to arrival with 2 rounds of .03 epinephrine and 50mg benadryl IV by EMS en route to facility

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe

Developed pain at injection site, pressure in chest and feeling of shortness of breath within an hour after first injection

Patient's daughter in law called to report the adverse event and will be submitting a VAERS as well. Pt rcvd first dose of vaccine 03/03 and 16 days later on 03/19 he was hospitalized for respiratory unrest, cause unknown. It was not suspected to be caused by the vaccine at that time. Doctors encouraged him to rcv the second dose and pharmacy staff was informed pt had been given the go ahead to do so. Pt marked that he was not currently ill on his informed consent form and that he had not had a previous reaction to the vaccine. 5 days after rcving his second dose (03/30) he arrested again resulting in hospitalization later death on 4/4.

The patient is a poor historian and history is obtained from him and his partner. His symptoms have started yesterday after receiving the second dose of a Covid vaccine. The couple went to eat a meal of Chinese food, and that evening the patient developed persistent nausea and vomiting. He had multiple episodes of emesis. According to his partner, he continued to have episodes of emesis this morning. The emesis was nonbilious and nonbloody, described as watery. The patient says he woke up this morning and may have felt some palpitations. He thinks the palpitations may have been worse than usual. He says he generally just felt unwell. He could not get out of bed and move around very much due to the nausea and vomiting. He says that for this reason, he activated EMS who brought him to the hospital. Regarding his atrial fibrillation, he says he is mostly compliant with taking his medications, however he did not take any of his home medications today.In the ER, he was hypertensive to 141/111 and tachycardic to 141, tachypneic to 23. His heart rate went up to the 170s and he was given multiple doses of IV metoprolol. On labs, he had a leukocytosis with a white blood count of 12 and the D-dimer was elevated greater than 20. CTA was obtained to rule out pulmonary embolism which was negative. However, down in the scanner he developed an episode of unresponsiveness with questionable seizure symptoms. He was treated with an LR bolus 500 cc but due to the findings of increased pulmonary vascular congestion, was diuresed with Lasix 80 mg IV x1. Blood cultures x2 were obtained.

Within 15 minutes of injection, patient became diaphoretic and dyspneic. BP 210/120, P-87 steady, O2Sat-97-99. Cold compresses applied and EMS notified. 2nd BP prior to EMS arrival was 160/135, O2Sat - 98. Symptoms improved within 10-15 minutes. EMS assessed patient and he was able to leave unassisted.

Onset ~3/24/21 c/o SOB, DOE, intermittent fever and N/D. SOB/DOE worsened. Sought care at Medical Center 3/31/21 and admitted to another hospital hypoxemic on room air and tachycardic w/ respiratory distress. CHF Dx w/ EF 15-20% on 4/1/21. OGT placed 4/6/21. Multiple infarcts 4/15/21. NGT placed 4/16/21. Acute Motor Axial Neuropathy (variant GBS) on 4/19/21.

one week after second dose, patient developed fevers, chills, cough and SOB. multiple SARS-COV 2 tests were negative, mulitple abx courses were ineffective CT Chest showed B ground glass consolidations patient underwent bronchoscopy which showed neutrophil predominance, but negative culture patient was treated with steroids and recovered

Hospitalization - comfort measures -acute on chronic combined CHF caused by ischemic cardiomyopathy with Cardiorenal syndrome + acute hypoxic respiratory failure, major decline, failed CABG

On day 16 after vaccination patient experienced sudden dyspnea, stridor, and respiratory distress/respiratory arrest followed by cardiac arrest. ACLS by paramedics, patient in PEA in field. Extubated on arrival to ER with no residual deficits

atrial fibrillation; shortness of breath; This is a spontaneous report from a contactable consumer reporting for himself. This 69-year-old male consumer received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 at 13:15, in left arm, for COVID-19 immunisation. The first dose of BNT162B2 vaccine was given on an unspecified date. No other vaccine was given in 4 weeks. Medical history included bladder cancer, blood pressure controlled by lisinopril and allergy to fentanyl. COVID prior vaccination: no. COVID tested post vaccination: no. Concomitant medication included lisnopril for blood pressure. On 07Apr2021 at 13:00 the patient developed shortness of breath and atrial fibrillation which never had before. No treatment was required. The events resolved on an unspecified date in Apr2021. Information on the lot/batch number has been requested.

Respiratory distress on exertion; Chills; Joint pain; first dose of BNT162B2 administered in left leg; first dose and second dose received on same day (08Mar2021); first dose and second dose received on same day (08Mar2021); This is a spontaneous report received from a contactable Other Health Professional (patient). A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration in the left leg and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: 8732) via an unspecified route of administration in the right arm on 08Mar2021 (at the age of 69-year-old) at 11:00 as a single dose for Covid-19 immunization in hospital. The patient had no allergies and medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included an unspecified blood pressure medication (within 2 weeks of vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced respiratory distress on exertion, chills and Joint pain. Patient did not receive any treatment for the events. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.

COVID-19 virus infection dyspnea on exertion that started 5 days ago that has progressed to him feeling short of breath even at rest Headache chest pressure

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

Clinical impression: Dizziness. ED Physician Note; Chief Complaint: Patient presents with Dizziness. History of Present Illness: Patient is a 69 y.o. male with hx of hypertension, anxiety, presenting to the ED with reports of dizziness which began upon waking up this morning. Patient states that he was recently diagnosed with COVID-19 viral infection on 3/19/2021. He states he was primarily tested secondary to a family member having confirmed infection. He states he has not had any significant cough, shortness of breath, fevers, chest pain, or difficulty breathing over the past few days. He additionally denies any dizziness or difficulty ambulating until this morning. He states this morning when he woke up he felt as though he was having an unsteady gait, reports "feeling like I am drunk". He denies any sided weakness, numbness/tingling, changes to his speech, or additional symptoms at this time. He additionally is denying any urinary symptoms, changes to bowel movements, or black/bloody appearing stool. He denies any prior history of vertigo or dizziness in the past. Exposure to COVID-19 virus.

Pfizer-BioNTech COVID-19 Vaccine : Pfizer-BioNTech COVID-19 Vaccine : patient presented to clinic with shortness of breath on exertion for one week. Obtained labs and imaging: found to have bilateral pulmonary embolism and left lower extremity DVT and sent immediately to emergency department where vitals were within normal ranges and the patient was not in respiratory distress. Long car ride 26 days prior to arrival. Patient received heparin, admitted to the hospital, transitioned to a direct-acting oral anticoagulant, and discharged to home medically stable. On follow-up after discharge patient is doing well and compliant with anticoagulation.

Client is fully vaccinated using Pfizer vaccine. Last dose on 3/25/2021. Tested positive for COVID -19 on 6/2/2021. Symptoms included: cough, shortness of breath, fatigue, headache, and runny nose. Vaccine given at hospital

felt out of breath; whole breathing experience was easier and stronger/usually have more mucus excretion in the morning, it has gone away/used to feel more stressed and being worked and I don't feel that anymore; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 19Mar2021 (Batch/Lot Number: EN8727) (at the age of 69-years-old) as dose 2, single for COVID-19 immunization. Medical history included patient had hepatitis A in the year 1975, mucus excretion in the morning, stressed and worked, and exercise (normally exercised, would do leg exercises, martial arts exercises, and upper boy exercises; done some weight for years). Concomitant medications included L-arginine; azithromycin (ZMAX); lepidium meyenii root (MACA 2H); all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly in left arm on 23Feb2021 (lot number: EN6201) (at the age of 69-years-old) for COVID-19 immunization and experienced fatigue, little achy, dizzy, lethargic, liver ache, ang drug interaction; and previously took ginseng and experienced liver ache and drug interaction (ginseng interacting with first dose of the vaccine). The patient reported that after the second vaccination, he felt that his whole breathing experience was easier and stronger. He usually had more mucus excretion in the morning, and it has gone away. He didn't have that any longer. His lungs felt stronger, like they accommodate (as reported). He used to feel more stressed and being worked and he didn't feel that anymore. He normally exercised, would do leg exercises, martial arts exercises, and upper boy exercises. He has done some weight for years. He hasn't really walked a lot, but he never had any stresses, he was very athletic. He never had any stress with walking. However, for the past few days with a few slight stairs, the patient felt out of breath. He went up a slight hill, and he felt out of breath and his legs needed to work a little bit more. The patient thought that maybe he needs to exercise a little bit more. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Thought he was going to die; Had labored breathing and stuff; getting spells of feeling like he is going to pass out.; Heart rate jumping up and down; light head and dizzy; experienced something like menopause, feeling heat from chest up to head; his heart rate is usually in the 90s and sometimes it drops into the 30 and seems to be all over the place; red hot; Myocarditis type symptoms; This is a spontaneous report from a contactable female consumer. A 70-Year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, batch/lot number: ER8734) via unspecified route of administration, in the left arm, on 29Mar2021 (at the age of 69 years), as a single dose for COVID-19 Immunisation. Medical history included heart disease. The patient family history included heart disease. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, batch/lot number: EN6206), via an unspecified route of administration, in the left arm, on 08Mar2021, as a single dose for COVID-19 immunisation. There were no prior vaccinations within 4 weeks. On an unknown date in Apr2021, about 2.5 weeks after he started having myocarditis type symptoms when he noticed it he was doing cardio and it was mild. He noticed it doing when he had laboured breathing and stuff which progressed to getting spells of feeling like he was going to pass out, his heart rate jumping up and down but his oxygen and blood pressure were fine. The patient stated his symptoms kind of changed and he was lighted head and dizzy when standing and now when sitting in the chair and it does it. He stated that he felt like it he had adrenaline and after talking to women and how they explain menopause that is the best way he can explain it, just like he is red hot and he stated it was really hard to explain, it was almost like if he experienced something like menopause where there is heat up to his chest and head. Caller stated he thought he was going to die, he thinks he was going to pass out, Caller stated he takes his blood pressure measurement 3-4 times a day and his heart rate is usually in the 90s and sometimes it drops into the 30s. It seems to be all over the place, but his blood pressure was the best it was ever been. The caller stated that the symptoms worsened from the original onset and now it was hard to say he will go a few hours without symptoms and then hits him or he will start out the day with symptoms and they go away. It was reported that the physicians were trying to currently treat the myocarditis and the doctors aren't quite sure what was going on. On an unknown date, the patient was hospitalized. He stated the doctors went in and had go in his veins and they checked his stents and couldn't find anything wrong. Caller stated he was on a monitor right now. Caller stated that he wished he had not received the vaccine now as he was fine before. The patient underwent lab test and procedure which included Blood pressure with a result of unknown. The outcome of the events was reported as unknown. Information on Lot/Batch number was available. Additional information has been requested

102 fever; SOB; sweats; chills; This is a spontaneous report from a contactable pharmacist. A 69-year-old male patient received BNT162B2 (Solution for injection) via an unspecified route of administration, administered in arm right on 11Feb2021 at 15:45 (at the age of 69-year-old) (Lot Number: EL3302) as dose 1, single for covid-19 immunisation. Medical history included congestive heart failure (CHF) (20 years), chronic lymphocytic leukemia (CLL) (25 year) and SARS-CoV-2 test positive on 15Dec2020. Concomitant medications included apixaban (ELIQUIS), simvastatin, sacubitril valsartan sodium hydrate (ENTRESTO) and furosemide. On 12Feb2021 at 06:00, the patient experienced 102 fever, shortness of breath (sob), heart rate (hr) about 90-100, sweats and chills for last 3 days and improving slowly. It was reported that the patient was tests positive nasal swab COVID on 15Dec2020. The patient was mildly sick 2-3 weeks. She was much more fit and did not feel well for a day or two (slight fever, too, CHF and CLL, WBC of 80,000 for 25 years). It was reported that the patient did not experienced arm pain. The patient was wondering if patient need the second dose with such a strong booster reaction. Hard on his heart. The outcome of the events was not recovered. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

Urine turned red, skin turned yellow, lost significant strength & got winded walking to the bathroom. Went to ER at Hospital on 02/20/2021. Hemoglobin level had plummeted to 7.6; it eventually fell to below 5.0. I was admitted to the ICU and, after a couple days, was transferred to the med/surg unit. I was administered whole blood, but my hemoglobin level would not stay above 7.0. On 02/27 I experienced a cardiac event due to my low RBC count and was moved back to ICU. From there, I was transferred by ambulance to ICU at Hospital in order to start Rituxan therapy. I was in ICU for a day and then transferred to the cancer care unit. I remained there until

Narrative: Symptoms: Dizziness, Myalgia, Fever & CoughWheeze Treatment: REMDESIVIR 200 MG ONCE 200mg on day 1 then 100mg on days 2-5 ,DEXAMETHASONE 6 MG EVERY DAY for a total of 6 days

Dizziness, Tachypnea, NauseaVomiting, HYPERtension, no other events occured Narrative: Employee c/o dizziness and nausea after 15 minutes of sitting, and then using the restroom. Sits back down and vs obtained. b/p 212/128 manual and machine. pulse and o2 normal. Patient continues to feel poorly, wants to lie down. Patient tachypneic, with some SOB. Has high b/p baseline, but says he took his b/p meds this AM. Hasn't had reaction to vaccines previously. Epi administered and 911 called, as patient agrees to this. A&O,pleasant and anxious. Transport to hospital for eval with paramedics.

Patient received first dose of COVID vaccine at 1800 and waited 15 minutes and left on his own accord. He sat in his car a few more minutes with his wife not feeling as if he was completely well. He returned to the clinic reporting tightness in his neck and throat area. His blood pressure was taken 189/99. He did not have difficulty breathing or any other signs of anaphylaxis but was given 50mg of benadryl as a precaution. We continued to monitor blood pressure for 30 minutes and did not resolve. He has a history of high blood pressure but reports that it is controlled by taking Metoprolol and Amlodipine daily. Physician was consulted and felt it was best to be seen in the ER. The patient was transported to ER by his wife and seen.

According to wife: On 1-21-21 night, the patient began having severe shortness of breath, trouble breathing, cough that wouldn?t stop, light headedness, and sore arm. On 1-22-21 , wife checked oxygen level and it was at 81%. Called ambulance, and the patient went to ED. The patient was transferred to the emergency room. The patient was Diagnosed with severe pneumonia and is on a ventilator. Unknown if related to vaccine at this time.

Pt admitted 22 Jan 21 with (HFpEF) heart failure with preserved ejection fraction; AKI (acute kidney injury); Acute kidney injury superimposed on chronic kidney disease; Acute on chronic diastolic congestive heart failure; Acute on chronic heart failure with preserved ejection fraction; Acute respiratory failure with hypoxia; Anemia due to stage 3 chronic kidney disease, unspecified whether stage 3a or 3b CKD; Anemia, unspecified type; COVID-19; Chest pain; Chronic pain syndrome; Gastroesophageal reflux disease without esophagitis; History of COVID-19; Hypertension, essential; Hypertensive heart and kidney disease with HF and with CKD stage II; Hypoxia; Peripheral vascular disease due to secondary diabetes mellitus; Prostate cancer; Shortness of breath; Type 2 diabetes mellitus with stage 3 chronic kidney disease, with long-term current use of insulin, unspecified whether stage 3a or 3b CKD as of today still hospitalized

when he pushes on the injection site, he does feel a little pain; feel a little tightness in his breathing/ tightness/shortness of breath; on his finger (pulse ox) showing he had 95% oxygen uptake, looked like 91% and then it went up to 93%; feel a little bit of heat on his forehead; nose dripping/nose was running; seems like it isn't working; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1283, via an unspecified route of administration on 13Jan2021 09:55 at a single dose on the Upper Left Arm, probably on muscle near the top for COVID-19 immunization. Medical history included shellfish allergy, asthma, hay fever, reaction/allergy to oleander plant (rash on his legs) and had surgery on his hip. There were no concomitant medications. The caller received Pfizer's COVID-19 vaccine early yesterday morning, 13Jan2021 and his second dose has been scheduled for more than 3 weeks. He also mentioned that his vaccine "seems like it isn't working". The patient stated it doesn't look like he had much of a response. All of his neighbor's arms are so sore and 'blah blah' and they have other side effects. He feels like everybody else had a much bigger reaction. He read there was a whole bunch of people that was given the COVID-19 vaccine with a short needle and all of their vaccinations had to be re-done. He really didn't feel nothing when he was being injection. He explained that when he pushes on the injection site, he does feel a little pain on 14Jan2021. However, he was heavily muscled in that area, and also based on his recent surgery on his hip and other experiences, he noticed on the surgeons files on his case, it says he has a high tolerance for pain which he believes to be true. He believes he may have been injected with a short needle. He was just wondering what size of needle is supposed to be used for the Pfizer vaccine and asked how he can find out what needle was used on him. He doesn't know if this was an intramuscular injection, but he assumes they were trying to get into the muscle. The patient stated he does have allergies, particularly to shellfish, but they haven't been really acting up a lot or that much. He told them about his allergies when he was receiving the COVID-19 vaccine, and they kept him for half an hour after receiving it on 13Jan2021. He did feel a little tightness in his breathing. He does have a little bit of asthma and he does have hay fever and all of that stuff. They put the little thing on his finger (pulse ox) showing he had 95% oxygen uptake, which is little low for him. The next time that checked it first looked like 91% and then it went up to 93%, but the way one holds their finger has something to do with that. He waited a few more minutes and assumed it was probably just allergies. He felt how it feels when he gets into pollen. He took a couple of puffs of his inhaler (Pro air HFA (albuterol sulfate) and the tightness very quickly went back to normal. The last reading when they put the pulse ox on his finger was 96.5. It should be 98 but at that point he talked to them and was feeling much better. He also mentioned he did feel a little bit of heat on his forehead last night (13Jan2021), he might have noticed it. However, the breathing stuff (Tightness/shortness of breath) started again. He used his inhaler again which would have been about 9 hours later, and he also took a Claritin as well. He doesn't normally take Claritin but he does take it every day up north and the last few weeks he did have his Condo wide open. The patient confirmed the tightness/shortness of breath wasn't immediately after receiving the COVID-19 vaccine, it was about 15-20 minutes after. The feeling felt no different than when he starts having a reaction to cigar smoke or something like that. The tightness/ shortness of breath improved immediately after using his inhaler. He used the inhaler which cleared up the tightness instantly as it always does but his nose was running kind of like when one has the flu. He clarifies he noticed late afternoon/evening; his nose was dripping. The dripping went on for 2-3 hours. He knew the inhaler wouldn't necessarily stop the dripping, so he figured he better take a Claritin. He stated not too longer after taking the Claritin, maybe 15-20 minutes afterwards when the Claritin started taking effect, the dripping stopped, and it hasn't been back since. He believes he took one Claritin a day before. The outcome of the event nose dripping was recovered, tightness/shortness of breath and 'on his finger (pulse ox) showing he had 95% oxygen uptake, looked like 91% and then it went up to 93%' was recovering, 'when he pushes on the injection site, he does feel a little pain' was not recovered while for other events was unknown.

Got shot at 8am 22 Jan. Slight soreness in arm developed later the same day, but no problem. Everything was normal and went to bed. Woke up approximately 2-3 h later with extreme vertigo, dizziness, imbalance, completely clogged left ear, tinnitus in left hear and nausea. Within about an hour I was hyperventilating and had cold tingling sensation in hands and feet. About 2am went to hospital. They did a bunch of tests including a CT scan which revealed nothing adverse. They kept me over night and gave me an MRI the next morning. Again nothing adverse found. I was released that next day with orders to see PCP. Got an appt 2 days later. PCP immediately started me on Prednisone and referred me to ENT doctor. Got an audio test 2 days later and because of the severity of my symptoms (sudden, acute tinnitus and complete hearing loss in left ear) ENT prescribed higher dose and duration of prednisone. I am on day 5 of the 24day course prescribed by ENT with no appreciable improvement. Still have no hearing in left ear and tinnitus, imbalance and trouble focusing and walking. No causal link has been ascribed to the vaccine, but I am terrified of having the booster shot which is schedule for 12 Feb.

light headed, extremely tired, shortness of breath, elevated pulse, and increased pain around the hip replacement

COVID-19 Pfizer Vaccine dose #1 12/21/20 (Lot EJ1685); Tubersol TB test placed on the same day COVID-19 Pfizer Vaccine dose #2 1/11/21 (Lot EL1284) 1/12/2021: Patient presents to ED via EMS for chief complaint -- He stated that he was diagnosed with COVID-19 in November 2020. The patient has not had any recent Covid 19 exposures. He has not congregated with family members and others for Christmas. He comes in for shortness of breath to the ED that is accompanied by fever. Prior to getting his Covid vaccine 19 he was seen good health. The patient finds that he short of breath, dyspneic on exertion, and feels overall weak and fatigued. He has shaking chills according to him. Patient is diagnosed with PE likely due to untreated DVT (Patient reports "taking girlfriend's coumadin") from 1/7.

Hospitalized for community-acquired pneumonia and sepsis 6 days following administration of COVID-19 vaccine, complicated by acute hypoxemic respiratory failure and acute kidney injury requiring. Admitted to ICU, treated with intravenous antibiotics and initial pressor support. Intubated on hospital day #3, extubated on hospital day #8. Remains in ICU at time of this report.

Sudden onset of acute respiratory failure with hypoxia and hyperglycemia Lungs filled with fluid, oxygen went down to low 80?s and coughing - could not breath. 911 Emergency to hospital.

Pt suffered Cardiac Arrest and respiratory arrest on 2/9/21 and passed away at a local hospital. He had multiple health conditions likely contributing to this. he arrested at home and CPR was attempted and unsuccessful. Pt received his Covid vaccine #1 on 1/27/21. No issues were noted after vaccine and was due for his 2nd dose next week. However, we were notified he passed away on 2/9/21. Very likely death not at all related to vaccine but wanted to document as patient was in the middle of the covid vaccine series.

he developed shortness of breath and weakness within 24 hours of vaccination. over next 72 hours, developed progressive symmetric proximal muscle weakness with labs/imaging c/w myositis. also had biochemical evidence of cell lysis (elevated uric acid, high K, low Ca, high phos). He received steroids 2/11 with near complete recovery in function by 2/12, but biochemical changes were already improving by time of steroid dosing.

1st Vaccine 2/6/21; developed chest pain with SOA on exertion 2/13/21; Seen in ED 2/16/21 for worsening symptoms and admitted to hospital.

Patient experienced throat tightness and a chunky feeling in his throat shortly after receiving the 1st dose of Pfizer vaccine. Patient was given 25 mg of benadry with some relief. Patient was sent by ambulance to emergency room and was treated and released. Noted that the emergency room doctor prescribed an epi pen.

I was having shortness of breath and my heart was beating way too fast and I started to monitor it with my blood pressure cuff and I noticed my heart rate was too fast. So I drove to the emergency room and they admitted me immediately. Diagnosed with Afib

02/07/21 through 2/13/21 slightly fatiqued, took all his prescribed medications, ate breakfast, lunch and dinner was drinking eight 10 oz bottles of water. On 02/14/21 was very tired had a difficult time breathing after taking the normal meds. He took a breathing treatment with his prescribed Ipratropium Bromide and Albuterol Sulfate via home nebulizer. This did not improve his breathing. He was very weak and breathing was labored. 911 was called by wife. 911EMTchecked pulse and breathing. Informed him they would give him a breathing treatment.He started to go limp. EMT's got him to Ambulance and to Medical Center to the ER. Heroics done. He died. Pulmonary and Cardiac Arrest

Very difficult breathing. Nasal passages became inflamed or swollen and could not breath easily through nose. When walking had to take deep breaths through mouth, heart pumped harder, etc.

Headache Fever/Chills Ringing in ears Loss of balance Visual distortion Nausea/gas Sharp stomach pain comes and goes Injection site soreness Gout flare up Cough/congestion Shortness of breath requiring oxygen Symptoms didn?t improve much for about 7 days

today he presents with complaints of dyspnea at rest, associated with a cough, abdominal and scrotal edema and bilateral leg edema. He also reports getting his 2nd COVID vaccine yesterday which causes him to have a 102 temperature and worsening cough. He reports a 30lb weight gain since January. He was on tikosyn for AF rate control which was recently stopped, but he was unsure why. He was regularly using CPAP machine, but stopped using about last year due to concerns with coronavirus. He was previously active going to the gym which she is also stopped during the pandemic due to inaccessibility

Headache and uneasy feeling for 4 days. Occasional chills, then fine for a day then again uneasy feeling in the head also felt congested and with breathing out hot air with dry nose. Thursday 2/25 went for a covid test that showed negative result. Feel normal on 3/3. Tylenol on 2/23 did not help much. Advil evening of 2/25 made me feel better on 2/26 uneasiness returned on 3/1 no chills but headache.

Chest pain, shortness of breath, feels like he can't catch his breath. presented to the emergency department with episodes of palpitations and chest pain. Around 530 this evening, the patient was in a store when he started feeling palpitations and irregularity to his heart rate. He states at that time, it did give him a mild anterior chest wall pressure. He denies any diaphoresis, pain radiation or lightheadedness at that time. Symptoms resolved after several hours.

Patient got first dose of COVID vaccine today and approx 10 minutes later he went to restroom and felt "like I was suffocating and could not catch my breath". denied any swelling, itching, or rash. patient has hx of COPD and wears home O2 at 3L.EMS was called and transported him to the Emergency room. He was given 3L oxygen and monitored for 2 hours. He was then discharged with the diagnosis of Dyspnea ( difficulty breathing)

Received COVID vaccine 1/26/21 and 2/12/21, and didn't have symptoms right after vaccine. Symptoms started Wednesday February 2/24/21 - started at 9PM that night preventing him from sleeping. Stated the chest pressure was like something "sitting on his chest". Also had body aches, chills, fever, fatigue, cough, and mild shortness of breath. Found to have heart failure, EF 25%

On 2/19/21 @ 11PM he was fine and had been talking laughing and playing his trumpet right up until bedtime Less than 2 hours later his wife was alarmed to hear him struggling to breathe When he tried to urinate he could only pass blood She called 911 @01:00 AM 02/20/2021 They administered oxygen and transported him to ED {this form won't let me fill in any of the shaded boxes} EMS said his lungs sounded like he had pneumonia Extensive testing focused on his lungs and kidneys as the source of infection and inflammation Please note that no source could be found! He was discharged home with strong steroids and antibiotics and instructed to use a inhaler 4x a day on 02/25/2021 5 days

deceased Narrative: Patient was a 68M with advanced ALS, long-term need for mechanical ventilation, total care, TF, who developed worsening respiratory failure increasing difficulty with mech ventilation, unresponsive to COPD exacerbation treatment, in the setting of persistently abnormal CXR findings concerning for malignancy or other processes. After discussion with family, they did not want to patient to suffer any more and asked for mechanical ventilation be stopped after adequate comfort medications were administered. Patient was allowed to pass away naturally from his underlying advanced ALS.

Back started itching then front stomach area and spreed to both side and neck. then hives started appearing. followed by Jagged spots with white ares and jagged round ring. Welt on rump x. chills, on and off. followed buy hot spot ankle side of shins and side of thighs. Went to ER IV Benadryl Took blood sample. Did CBC & Differential. Comprehensive Metabolic Panel. After a few hours the Red color in my forearm started to disappearing. Gave me a prescription for Benadryl and Famotidine 20mg ,Prednisone 50mg. Returned to ER next day as swelling started back up. IV Benadryl sent me home. No improvement. Dr changed to Hydroxyzine 25mg. home no improvement and Most of my body was covered. I had hot spot Hot spots feet, shins, thigh, fore arms. Put wet towels on hot spots to stop pain and itching. change ever 30 minutes no sleep for days Finally got in to DR he increased the famotidine to 40mg. Around 3am I finally slept, When I woke My lip was swollen and my throat was tight had a lump in it. drank water and ate a cookie. would not clear gaged down the Medication some dissolved before I could get them down. Drove to the hospital. They gave me injection in my thigh and IV Benadryl. Added Loratadine and had me get a Epinephrine Pen. Dr increased the medication. Very slowly the welt, and hives started changing to red rash, hot spots and itching continued. only got short sleep during the day and night at times exhausted. coughed several times for minute non stop. Slight fever followed by chills and some shaking. Very nervous at times. As thing started getting better I took some pictures. Could not believe what my body was going threw. March 18 finaly starting to go away getting better skin wise but still cold and hot. Mouth all this time would go from no taste to bad taste. Throw up feeling at times had to fight it off. March 16,17, after I would fall asleep I had very bad pounding headache took Aspirin and Tylenol. after three hours put a wet towel on my forehead. finally let up and was able to sleep a little. the second night same thing except after I went to sleep the towel dropped my core temperature could not get warm took temp 94.4. Turned heat back up to 78 degrees Wrapped upper body as had to keep lower legs in open air with wet towels on hot spots. Stopped taking my Blood Pressure and switch to from Hydroxyzine to (Banophen Diphenhydramin ) The spots are finally getting smaller. Feet are still swollen and are hard to walk on, still have to go everywhere in open slippers and pant legs rolled up. blisters broke on ankle finally getting better. March 20 left foot still swollen and stiff, right foot swelling going down a little. I could not handle filling this out until now. My memory and even my eye site was affected. I had to write it down in case some one asked me. When they asked me I couldnt remember everything. has to look and my notes to remember. Finally got a referral to infectious disease and a allergist.

admitted to inpatient medicine floor on 02Mar2021 for COVID-19 pneumonia; increasing O2 (oxygen) requirements; This is a spontaneous report from a contactable pharmacist reporting for a patient. A 70-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), intramuscular, administered in Arm Left on 24Feb2021 as SINGLE DOSE for covid-19 immunisation at 70 years old on a hospital. Medical history included colitis ulcerative, rosacea, systemic lupus erythematosus from an unknown date. It was unknown if other vaccines were given in four weeks. No COVID prior vaccination. Concomitant medications included hydroxychloroquine taken for systemic lupus erythematosus; sulfasalazine taken for an unspecified indication; mercaptopurine taken for colitis ulcerative; and doxycycline (DOXYCYCLINE) taken for rosacea; all start and stop dates were not reported (other medications in two weeks). The patient was admitted to inpatient medicine floor on 02Mar2021 for COVID-19 Pneumonia (onset date 02Mar2021). The patient was transferred to ICU on 04Mar2021 given increasing O2 (oxygen) requirements (onset date 04Mar2021). Treatment included dexamethasone and tocilizumab. The patient underwent lab tests and procedures which included Nasal Swab (PCR) (Sars-Cov-2 Test): positive on 02Mar2021. Outcome of the events was unknown.; Sender's Comments: The event COVID-19 pneumonia is likely an intercurrent condition and unrelated to suspect drug BNT162B2. Full immunity is expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called.

Fever, low oxygen saturation, severe encephalopathy, kidney failure, bilateral pulmonary infiltrates, sepsis, tachycardic, acidotic, intubated on ventilator since admission, paralyzed/sedated, ABG results showed high CO2 and O2 retention, edema, electrolyte imbalance, ARDS, low hemoglobin and hematocrit levels, blood transfusion needed

Shot given on 1/29 Flu symptoms started on 2/5 Ambulance ER visit with Flu diagnosis and later Covid diagnosis on 2/10 but sent home 2/11-2/13 progressively worsened with high fever starting, unable to walk from weakness and trouble breathing with coughing Taken by ambulance to Hospital on 2/13 and admitted to ICU 2/15 put on vent 3/22 switched from ET tube to tracheostomy 3/23 moved from ICU to LTAC still not fully awake and coherent and still on vent as of 3/24/21

Around 6 p.m., my throat tightened up somewhat significantly and lasted maybe 5 to 10 minutes. I wasn't choking, but I was coughing some. I kept drinking cold water, but it really didn't help much.

PMH COPD not on supplemental oxygen therapy, CPAP, HTN, DMII, former tobacco abuse presented to the ED with SOA. Symptoms began 3/26 after 2nd COVID vaccine. No fever, chills, CP, palpitations. Patient was hospitalized here in the fall with acute resp failure due to COVID, and developed PE for which he was on eliquis until recently

Patient presented and was admitted through the ED for with altered mental status and respiratory distress. COVID positive today. On arrival to ED patient was obtunded, nonverbal and was orally intubated. Patient has history of chronic atrial fibrillation and on arrival to ED patient was significantly tachycardia. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

Patient experienced severe leg and arm pain (bilaterally) as well as some subjective shortness of breath approximately 12 hours after the second dose. Nurse advisor recommended patient be acutely evaluated. Patient presented to ER for evaluation and was discharged without further consequence.

swelling of lips; swelling of throat; change in voice; IgE (prior to ER trip) was already signif elevated; diffuse itching; hives; Itching became more continuous , hives increased; elevated dimer titer; This is a spontaneous report from a contactable Other-HCP reporting for self. A 70-years-old patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Patient received the first dose on 20Jan2021. Medical history included Asthma, allergies to Penicillin, some molds, house dust, cat and dog dander. Concomitant medication included valsartan (DIOVAN); amlodipine; hydrochlorothiazide (HCT); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); bupropion hydrochloride (WELLBUTRIN). Within about1 week of injection, on 18Feb2021, patient experienced diffuse itching, site moving around, then later 2-3 hives. Patient had to d/c the antihistamine he take routinely (25Feb2021) for an allergy scratch test a week later. Itching became more continuous, hives increased. Had scratch test. Only localized reaction. Then hives increased, by 10Mar2021 hives bloomed all over body -- first on both forearms, then everywhere. Later in evening 10Mar2021, swelling of lips, throat, change in voice went to ER. Multiple Blood tests, chest MRI, neck ultrasound (localized swelling), cardiac stress test, and u/s of legs to r/o DVT because of elevated dimer titer (no clinical symptoms). All tests normal except dimer. IgE (prior to ER trip) was already signif elevated: 471 IU/ml on 25Feb2021 (Norm<114). Patient was hospitalized for these events for one day. Patient also Emergency Room Visit and Physician Office Visit for these events. Treatment included Inject of steroid, Benadryl, Prevacid, IV fluid. Patient had Nasal Swab on12Mar2021 with negative result. Outcome of events was recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events itching, hives, swelling of lips, throat swelling, voice alteration and IgE increased. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Per triage note of 4/7/2021: "Chief Complaint: pt presents with Nausea & vomitting, ha, body ache, unable to sleep, swollen feet. Symptoms started 3/25 after he recieved his 1st covid vaccine. has had to use a walker and gets SOB. pt had COVID 11/2020" Assessment reveals mild CHF, positive troponin, myocarditis per physician's notes of 4/7/2021 Patient treated with Zofran 4 mg IV and given 500 ml NS IV then Lasix 40 mg IV. Patient transferred to Medical Center 4/7

Mid Scapular Stabbing Pain; Shortness of Breath; Chest Pain; diagnosed with Bilateral PEs; Headache; Fatigue; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm, on 24Mar2021 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included pancreatic cancer from 2015, biliteral pulmonary embolism (PE) from 2015, and mild chronic obstructive pulmonary disease (COPD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, taken within 2 weeks of vaccination, included citalopram hydrochloride (CELEXA), umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA), and azelastine hydrochloride (ASTEPRO). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6198), in the left arm, on 03Mar2021 at 11:30 (at the age of 70-years-old) for COVID-19 immunization and experienced intense left sided neck pain and stiffness. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache and fatigue on 28Mar2021 and mid scapular stabbing pain, shortness of breath, chest pain, and diagnosed with bilateral PEs on 30Mar2021. The patient was hospitalized for all of the events from 30Mar2021 to 01Apr2021 for two days and the events were reported as life-threatening. It was reported that the bilateral PEs were diagnosed in the emergency department (ED). Therapeutic measures were taken as a result of all of the events, which included heparin (MANUFACTURER UNKNOWN) drip during inpatient stay and then transitioned to an unspecified treatment. The clinical outcome of headache, fatigue, mid scapular stabbing pain, shortness of breath, chest pain, and diagnosed with bilateral PEs was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

death Narrative: 70 yo male received COVID19 vaccine on 2/16/2021 (first dose) without complications. Patient was admitted to the facility on 3/12/2021 and transferred out to a hospital on 3/15/2021. Patient died on 3/24/2021 due to acute respiratory failure at a medical center. This report is being written because patient received Pfizer covid19 vaccine, Facility requires we report to VAERS if death occurs within 42 days of vaccination. Prior to his hospital admission, his previous one was 5/11/2020-5/14/2020. Please see below for hospital course at the Facility: 70 yo male with PMHx of COPD, CHFrEF 20%, CAD s/p MI and CABG in 1999, HLD, HTN, DM2, GERD, Anxiety and Depression who presented with increased shortness of breath to facility. Transfered on 3/13 to the facility. Noted increased SOB without CP, palpitations, cough, orthopnea or PND. No history of home O2 use but required 2-3L O2 during this hospital stay. Was noted on admit to Facility to have troponin elevation with unchanged EKG. Was started on NSTEMI protocol with heparin ggt, ASA, BB, and statin. Initially received one dose ceftriaxone/azithro for possible PNA. On admission, primary team held home BB. On arrival to Facility, troponin at 3.998 trended to 4.442 and then trended down. underwent CTA to evaluate for PE that was negative. CXR and CT showed pulmonary edema consistent with HF exacerbation and a proBNP 8613. Patient was given 40mg IV lasix x2. RRT was called twice, once for BP 80/50 treated with 500ml IVF, and second for CP that resolved with NTG and tramadol. Cardiology was consulted with goal to cath patient, however some concern for medication adherence going forward so they will reevaluate. Patient began to have tachycardia with rates in the 150s sustained and hypotension. EKG showed likely sinus tachycardia with wide QRS similar to prior EKGs. Patient has ICD in place that was interrogated and showed good function. IV metoprolol 5mg given x3 with rated decrease to upper 120s. Patient remained asymptomatic, awake, and alert. Per discussion with wife after transfer, patient BP has been in the 50s systolic at home for the last month. Cardiac cath was performed showing 99% stenosis of LCX. Did not tolerate procedure with nausea, vomiting, and altered mental status. RRT was called after cath procedure. He is nauseous, diaphoretic. He complained of chest pressure. STAT EKG obtained. Noted ST depressions in the septal leads significant from before. Cardiology concerned pt was having an inferior MI. STEMI call was activated and hospital cath lab was called and report given to the cardiologist on call. Pt was then transported to the Facility and he passed away on 3/24/2021.

5 days after 1st dose mildly sick for 1 day. 11 days after 1st dose severe attack of arthritis in my right hand only for a day. 18 days after 1st dose an attack of Bells Palsy on left side of face with a severe headache for several hours. These symptoms were similar to but more severe than those that were experienced prior to treatment of chronic Lyme Disease. 1 day after 2nd dose extreme arm and upper body pain. Day 2 after 2nd dose extremely ill. Day 3 after 2nd dose extremely ill with difficulty breathing. Almost wentto ER but the next day I was fine.

Patient with COPD on 4L of 02 complained of difficulty breathing and S.O.B. Onsite EMS was called vitals HR 104 BP 148/80. EKG presented with abnormal rythm patient was transported to the hospital.

4/22/21 Patient admitted to hospital for COVID D/C summary: Clinical Summary a 70 y.o. male with a history of HTN, prostate cancer, chronic pain, T2DM, OSA noncompliant with CPAP who presented to ED 4/22/2021 with scant hemoptysis. Found to be COVID+ and hypoxic requiring 2L NC. Cr. 1.4. He was transferred for further evaluation and management. Improved with Remdesivir and steroid therapy. Patient completed 3 doses of remdesivir, recommended completion of steroid therapy (5/2) and repeat outpt CT Chest. 1. Acute Hypoxic Respiratory Failure: requiring 2-3L NC on admission in setting of COVID-19 pneumonia. CTPA with no PE, patchy multifocal ground glass opacities, mildly enlarged mediastinal and hilar LAD, likely reactive. Pulmonary hygiene. Weaned off of O2 4/24/21. Home o2 evaluation with patient desaturating to 91% with exertion. 2. COVID-19 Pneumonia: symptoms began 4/20/2021 with headache, fever, chills and diarrhea. Presented with scant hemoptysis. COVID + 4/22/21. Febrile to 101 on admission. CTPA as described. Hypoxia as described. Started decadron (stop date 5/2), scheduled albuterol, mucinex. Monitor respiratory status. Pulmonary followed, initiated Remdesivir 4/23 following improvement in renal function. Recommended completion of 10 days of steroid therapy. Recommend repeat CT chest in 4-6 weeks for resolution.

Back started itching then front stomach area and spreed to both side and neck. then hives started appearing. followed by Jagged spots with white ares and jagged round ring. Welt on butt x. chills, on and off. followed buy hot spot ankle side of shins and side of thighs. Went to ER IV Benadryl Took blood sample. Did CBC & Differential. Comprehensive Metabolic Panel. After a few hours the Red color in my forearm started to disappearing. Gave me a prescription for Benadryl and Famotidine 20mg ,Prednisone 50mg. Returned to ER next day as swelling started back up. IV Benadryl sent me home. No improvement. Dr changed to Hydroxyzine 25mg. home no improvement and Most of my body was covered. I had hot spot. Hot spots feet, shins, thigh, fore arms. Put wet towels on hot spots to stop pain and itching. change ever 30 minutes no sleep for days Finally got in to DR he increased the famotidine to 40mg. Around 3am I finally slept, When I woke My lip was swollen and my throat was tight had a lump in it. drank water and ate a cookie. would not clear gaged down the Medication some dissolved before I could get them down. Drove to hospital. They gave me injection in my thigh and IV Benadryl. Added Loratadine and had me get a Epinephrine Pen. Dr increased the medication. Very slowly the welt, and hives started changing to red rash, hot spots and itching continued. only got short sleep during the day and night at times exhausted. coughed several times for minute non stop. Slight fever followed by chills and some shaking. Very nervous at times. As thing started getting better I took some pictures. Could not believe what my body was going threw. March 18 finaly starting to go away getting better skin wise but still cold and hot. Mouth all this time would go from no taste to bad taste. Throw up feeling at times had to fight it off. March 16,17, after I would fall asleep I had very bad pounding headache took Aspirin and Tylenol. after three hours put a wet towel on my forehead. finally let up and was able to sleep a little. the second night same thing except after I went to sleep the towel dropped my core temperature could not get warm took temp 94.4. Turned heat back up to 78 degrees Wrapped upper body as had to keep lower legs in open air with wet towels on hot spots. Stopped taking my Blood Pressure and switch to from Hydroxyzine to (Banophen Diphenhydramin ) The spots are finally getting smaller. Feet are still swollen and are hard to walk on, still have to go everywhere in open slippers and pant legs rolled up. blisters broke on ankle finally getting better. March 20 left foot still swollen and stiff, right foot swelling going down a little. I could not handle filling this out until now. My memory and even my eye site was affected. I had to write it down in case some one asked me. When they asked me I couldnt remember everything. has to look and my notes to remember. Finally got a referral to infectious disease and a allergist.

patient passed away, due to what was being told as possible blood clot in lungs; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Lot Number: ER8633) (at the age of 70-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not experienced COVID-19 prior or post vaccination. The patient passed away, due to what was being told as possible blood clot in lungs (on 07May2021). The event was serious (fatal) and required emergency room visit. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: blood clot in his lungs

3/21, admitted day after covid vaccine. Presented with shortness of breath, cough, but guarding on abd exam/wincing with moderate palpation. Reports he is making urine, denies dysuria frequency. Urine culture grew contaminating flora. Abscess culture growing heavy MRSA. Recommended IV vancomycin inpatient and then can transition to oral doxycycline 100 mg twice daily for least 2 to 4 weeks. Follow-up with Dr. in neurology clinic after discharge.

Patient is a 70 year old male with past medical history of HIV (most recent CD4 count 378/ viral load negative on 3/31), latent TB treated in 2019, alcoholic cirrhosis, Hypercholesteremia comes in from his neurologist office for concern for AIDP, CIDP. His symptoms started back in March of this year. He received his COVID vaccine (second dose) on March 6th and then went on a trip out of the country where he went deep sea fishing from March 7-15th. Three days later, on March 18th he developed a flu like illness, fevers, chills, headache, cough and diarrhea one week later. His COVID test at that time was negative. He reports that he drank the water in other country and also used ice cubes at smaller restaurants when he went out to eat. He denies eating any raw/ uncooked foods. His wife states that he typically walks 5 miles per day normally however since his trip, he has had to use a walker and needs assistance when walking. He is followed closely by a Dr in ID clinic for his HIV and was found to have positive stool cultures for Blasto and Giardia. He was treated with Tinidazole and his repeat stool studies were negative. Since that time, he has been experiencing worsening GI bloating and abdominal distension, back pain, and trouble walking. He was seen by NSG for his back pain however his scans showed bilateral degenerative changes. He was seen by GI and was given lactulose without improvement in his symptoms. CT head at that time showed evidence of ventriculomegaly however he denies urinary and bowel incontinence. He reports worsening shortness of breath and states that he "feels like a balloon is inside his stomach" He feels a band like sensation across his abdomen and states that his symptoms are worse at night time. He has not been walking since May 7th and has basically been immobile.

May 17, 2021: sever shortness of breath, low grade temperature, muscle aches for 2 weeks. Worsening. ER Hospital on May 30, 2021. Diagnosis: DVT (left leg); multiple PE's bilateral lungs

Vomiting; dry heaves; difficulty breathing; weakness; shaking; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 18May2021 13:00 (Lot number unknown as not available/provided to reporter at the time of report completion) as 2ND DOSE, SINGLE DOSE for covid-19 immunization, at facility as "pharmacy or drug store". The patient's medical history included High Blood pressure (BP), Chronic obstructive pulmonary disease (COPD), Prior history of stroke (not ongoing). The patient was diagnosed with COVID-19 prior to vaccination (not further specified). There was no known allergies. Concomitant medications (other medications received within 2 weeks of vaccination) included lisinopril, nicotine pills, blood thinners, and inhaler for COPD. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of bnt162b2 intramuscular on 27Apr2021 (at the age of 70-year-old) (Lot number unknown as not available/provided to reporter at the time of report completion) for covid-19 immunization. On 19May2021 13:00, the patient experienced Vomiting and dry heaves, difficulty breathing, weakness, shaking, headache, chills. Per the patient, the events were serious as requiring hospitalization. No resulting in death, life threatening, disabling/incapacitating, nor congenital anomaly/birth defect. The events resulted in Emergency room/department or urgent care visit. The patient was not sure if treatment was received for the events. The outcome of the events was recovering. It was unknown if the patient has been tested for COVID-19 since the vaccination. No follow-up attempts are possible; Information about batch number cannot be obtained.

I had problems with breathing; headache; went into itching; fever with chills; fever with chills; fatigue (slept all day Sat); body aches; balance issues; This is a spontaneous report from a contactable consumer reported for himself. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: EN6108) via an unspecified route of administration in arm left on 05Mar2021 09:45 AM as 2nd dose, single dose for COVID-19 immunisation. The patient medical history included afib, mouth cancer and known allergies were codeine. The patient's concomitant medications included glucosamine (GLUCOSAMINE), apixaban (ELIQUIS), tamsulosin (TAMSULOSIN), and multivitamin. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: L9264) via an unspecified route of administration in arm left on 12Feb2021 09:45 AM as 1st dose, single dose for COVID-19 immunisation. No other vaccine in four weeks. No treatment received for adverse event, no covid prior vaccination, did not tested covid post vaccination. On 05Mar2021, 01:15 PM patient experienced headache, went into itching, fever with chills, body aches and fatigue (slept all day Sat). Wake up every hour during the night to use the bathroom, felt like throwing up, once but nothing happened. Had balance issues. Sunday evening through Tues had problems with breathing. The clinical outcome of the event was resolving. No follow up attempts are possible. No further information is expected

63 PMH: HTN, multiple sclerosisALL: deniesVS: 96%, HR 54, BP 171/84 (no meds taken today) Symptoms: This is Dose#270yF developed immediate dizziness, heavy feelin in her body and legs. Felt like someone was squeezing her throat but denied difficulty breathing and mouth swelling. She felt slightly disoriented and said she had a recurrence of her speech difficulty which happens with her MS.She refused epinephrine administration for throat tightness but accepted 25mg IM benadryl. Assessment: slightly flushed appearing, complete sentences, coherent, alert and oriented. chest is clear, good air entry bilaterally, no respiratory distress or facial/oropharynegeal edema noted. Heart rate mildly decreased on auscultation. No distress. Treatment: 25mg IM benadryl Patient observed for 30 minutes with symptom resolution and driven home by companion.Repeat vitals O2- 97%, HR- 57, BP - 131/69

PT. DEVELOPED SOB, NAUSEA, VOMITING, FEVER ADMITTED TO HOSPITAL 6/12/2021 REPORTS FAMILY ALL VACCINATED BUT TESTED POSITIVE ALSO STILL INPATIENT

Patient presented to the ED and was subsequently hospitalized for COPD exacerbation, acute bronchitis within 6 weeks of receiving COVID vaccination.

Slightly swollen throat; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN53118), via an unspecified route of administration, administered in arm left on 05Feb2021 08:00 as 1st dose, single for COVID-19 immunization, (age at 70-year-old). Medical history included Gout, High Cholestrol & Enlarged Prostrate, food allergy (some Fish (not iodine). The patient previously took keflex and experienced drug allergies. The patient's concomitant medications was not reported. No other vaccine in four weeks. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Feb2021 08:30, the patient experienced slightly swollen throat. Treatment medication included OTC Benadryl for the event. Outcome of the event was reported as recovered. Follow-up attempts completed. No further information expected.

Fluid subsequently tested positive for mesothelioma; Fluid was drawn from patients lungs; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (Pfizer employee). A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration on an unspecified date in Mar2021 (age at vaccination 70-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via intramuscular route of administration on an unspecified date in Feb2021 (age at vaccination 70-year-old) at dose 1, single for covid-19 immunisation. It was unknown whether the patient was diagnosed with COVID-19, prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021 patient experienced Shortness of breath, this led to emergency room visit and physician office visit during which fluid was drawn from patients lungs, fluid subsequently tested positive for mesothelioma. The patient underwent lab tests and procedures which included Fluid was drawn from patient lungs: positive for mesothelioma on an unspecified date in Mar2021. Patient received treatment for adverse events. The case was reported as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/ Congenital anomaly/birth defect). Outcome of the event was resolved on an unspecified date in 2021. Information on lot/batch number has been requested.

has been in bed x16 days; his breathing is worse; he had the weird prickly headache again; he is really having a hard time breathing; tired; has no appetite; the patient said he feels like he has been hit by a big truck.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 16Mar2021 at 12:45 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 23Feb2021 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization and experienced having a hard time breathing; in bed for 8 days and couldn't get out of bed; couldn't hardly eat, and had no appetite; really bad headache, a prickly headache; sweating but wasn't running a fever; really tired; and he was in bed for 8 days and couldn't get out of bed. The patient's medical history included COPD, diagnosed at least 10 years ago; and High Blood Pressure, Diagnosed maybe 15 years ago. The patient's concomitant medications included Felodipine for High Blood Pressure, 5mg once a day; Pro-Air for COPD, 90mcg PRN, Rescue Inhaler as needed, been on for at least 5 years; Spiriva for COPD, 2.5mcg 2 puffs a day, been on for at least 5 years; Breo for COPD, 200mcg one puff a day; and Albuterol for COPD, 0.083% use 1 vial, up to 4 times a day as needed. On 16Mar2021, the patient experienced he had the weird prickly headache again; he is really having a hard time breathing; has been in bed x16 days; tired; has no appetite; the patient said he feels like he has been hit by a big truck; and on an unspecified date his breathing is worse. The treatment received by the patient was started taking Advil a couple of days ago and it is dulling it. States she read that he should not be taking anything right away because the body needs to react to vaccine. States he is using his normal medications and increasing the frequency of his nebulizer. The outcome of event his breathing is worse was unknown and for all other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

My oxygen saturation also fell to a low of 93 when it's usually 96-97; shortness of breath; chest pressure; my resting pulse surged to 98 to 114 over the next 3 hours. My resting pulse is usually 75; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received second dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number: EN6200), via an unspecified route in the left arm on 27Feb2021 at 15:30, as a single dose for covid-19 immunization. Patient medical history included polycythemia vera and known allergies to NSAIDS, citrus, caffeine. Patient concomitant medications included irbesartan, atorvastatin, omeprazole and acetylsalicylic acid (BABY ASPIRIN). Patient historical vaccine included first dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number: EL9261), in the left arm on 06Feb2021 at 15:30, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 28Feb2021 at 12:15, approximately 20 hours after my 2nd Covid vaccine shot, patient experienced chest pressure, shortness of breath and resting pulse surged to 98 to 114 over the next 3 hours, his resting pulse is usually 75. Her oxygen saturation also fell to a low of 93 when it's usually 96-97. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included resting pulse surged to 98 to 114 his resting pulse is usually 75 and oxygen saturation also fell to a low of 93 when it's usually 96-97 on 28Feb2021. The clinical outcome of the events was recovering as by 42 hours after the shot, patient was pretty much back to normal although he had some lingering chest pressure and resting pulse was now in the low 80's. No follow up attempts are possible. No further information is expected.

Tiredness; headache; muscle pain; chills; joint pain; fever; nausea; difficulty breathing; dizziness; weakness; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6199) via an unspecified route of administration in the left arm on 12Mar2021 at 12:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to generic codons. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) from an unknown date and for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 17Mar2021 at 12:00, 5 days after vaccination, the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, nausea, difficulty breathing/shortness of breath, dizziness and weakness. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event tiredness, headache, muscle pain, chills, joint pain, fever, nausea, difficulty breathing/shortness of breath, dizziness and weakness were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Fatigue, body aches, initially, June 29, 30th. Then fever and respiratory difficulty July 6 and 7th. Cough on July 8th, then labored breathing on July 10th, went to the ED.

Onset Persistent Atrial Fibrillation / Flutter with rapid ventricular response 2/14/2021 as indicated on my PPM. I developed heart failure symptoms and no longer was able to Jog or rode bike due to DOE, lightheadedness and on hills had chest pain and feeling of near syncope demanding immediate rest. Increased Toprol Xl 100 mg daily and Flecanide 100 mg bid didn't help and the latter likely contributed to "Flecanide Flutter" and my new heart failure with EF of 46%. My heart failure symptoms immediately improved off flecanide and on Digoxin, but my symptoms totally reversed after elective cardioversion and Atrial Ablation therapy 6/10/2021.

Pt Recieved firts Pfizer covid shot on May 7 , ( Shot was given at Pharmacy ) over the next week, not feeling well, body aches, headache, ect. by the started felling better on the 15th of May , then took a turn for the worse. On the 18th, hypodermic Temp 95, severe dyspnea on May 19th. Pt was checked into Medical Center, on the 19th May. A Lymphnode on his Clavicle was found and was found to have lymphoma. Also, his Sister, believes that he had his second Pfizer Covid shot on May 20. and that he tested pos for Covid. He was sent home on the 4th of June. He came back to my emergency room on the 10th of June for respiratory failue., was intubated and sent to the ICU where he expired on June 24.

Suspect Covid breakthrough- came through ED and now admitted per caller, 7/27/2021 Vaccine #2 from Pfizer, 03/03/2021, caller did not have injection site Patient came into ED for Covid swab and symptoms on 7/25/2021 and then admitted Patient is hospitalized still

Approximately 10 days after 1st dose, complaint about pain running from lower to upper inside of left leg. Second dose given on 5/19/21. On 5/21/21 had an ultrasound of left leg. Acute deep vein thrombosis found. On 5/22/21, complained of pain in back when breathing. Hospitalized overnight with acute pulmonary embolism.

Pt presented to ED 1/12 complaining of shortness of breath and nonproductive cough which onset approximately 8 days ago. Tested positive for COVID. Remains admitted for management of COVID.

Angina at rest; Chest pain; Dyspnea, unspecified type; NSTEMI (non-ST elevated myocardial infarction); SOB (shortness of breath)

On Monday night, after the vaccination on Friday, about 10:00 I began to feel pain in my neck, both shoulders, and across my chest. Sleep was fitful and finally impossible, with every breath being painful. We went to ER about 6:00 A.M., thinking it was either a heart attack or COVID. I was checked very well, with good results. EKG was fine, Oxygen at 97%, chest x-ray looked good, white blood count was good, but platelets were low. A subsequent flu test and COVID test both came back negative. My symptoms were constant for several hours then diminished, increased, and diminished until Friday when I felt largely symptom free.

15 hours after injection (3AM) felt mild congestion in lungs and nose. Heard that lying on stomach was preferred. Did that, and woke up at 6AM; was fine. No other symptoms.

71 year old with HTN, HLD, CAD s/p CABG, ischemic cardiomyopathy, AAA s/p EVAR, and COPD presented for elective left heart cath without intervention. Allergy consulted due to anaphylactic reaction several hours after procedure. Patient was stable on RA at time of presentation and vitals were normal and stable during the procedure from 8-9 AM. Procedure log reviewed. He received fentanyl, versed, heparin, omnipaque, and xylocaine during the procedure. No immediate reactions noted and no change in vitals during procedure. He tolerated procedure well and was transferred to the cardiac recovery room on RA with normal vitals.   At 1217, patient received percocet and at 1 PM, desaturations noted on flowsheets (84% from RA). Noted pain level of 10/10. HR increased to 130s-150s and BP did drop as low as 99/87. Per notes, he developed shortness of breath, rash, and itching with this. Given albuterol, racemic epinephrine, diphenhydramine IV, famotidine IV, and solumedrol. After developing nausea, he was given IM epinephrine at 2:10 pm. Then, symptoms rapidly improved and he was transferred to CVICU. He was shortly weaned from BIPAP (briefly hypercarbic) to nasal cannula and eventually 1-2L NC.

Patient received his first Pfizer COVID-19 vaccine on 2/9/21 at 2:23 pm. Patient had experienced mild respiratory symptoms the day of vaccination. Patient reported more severe respiratory distress such as tightness of chest and shortness of breath on 2/15/21. He also had a fever. Patient went to an urgent care clinic and was tested for COVID-19. He received antibiotics for possible respiratory infection. 2/17/21 patient reports improved symptoms and no fever. Client is taking antibiotics and is using supplementary oxygen with his CPAP PRN. Checked in with patient on 1/23/21 and patient has improved. Client has a productive cough and has finished his course of antibiotics.

The patient started having right sided chest pain/rib pain minutes after receiving the 2nd dose of Covid 19 vaccine. When he presented to the medical treatment area he was c/o this right sided chest pain that was worsened by inspiration. The pain was non-radiating and was also associated w/ shortness of breath. He has been experiencing shortness of breath intermittently over the past couple of weeks. The patient denied associated dizziness, lightheadedness, nausea, vomiting, abdominal pain, vision changes. He noted that he has a prior history of DVT and PE, but is not on any anticoagulation medications. He is currently being treated for bacteremia from a dog bite wound and receiving IV antibiotics through a port. He also has hx of CLL, currently on oral chemotherapy medication.

Pt. c/o feeling flush in the face and slight chest congestion. Pt. voice that he had a history of bypass and ablation. Pt. seen and assessed by EMT and vitals are: Bp 140/90, HR 74, O2 97%. After 20 min. of observation pt. voiced that he felt ell enough to go home and was cleared to do so by EMT.

There were no immediate reactions during the 15 minute wait period. 45 minutes after my injection, while at a different Walgreens where my friend received a Moderna jab, I was hit with a rush of side effects. The first was a deep gripping pain in the diaphragm area, like a punch to the stomach with some dizziness. While seated, my left leg experienced increasing pain from foot to hip. In short order, my left foot grew completely numb and this extended up my calf to my knee. My foot became paralyzed. Rather than go through a lengthy emergency room procedure, we drove back and luckily, the numbness did not spread. The intense leg pain remained steady. Breathing labored. At my friend's house, the left foot & calf numbing and paralysis finally subsided 4.5 hours after injection. At home, some numbness returned but subsided. Sat. through Wednesday, 2-28 to 3-3-21: Weakness in left leg. Cramping of calf muscle. The chest cavity pain began to intensify. Chills arrive plus daily headaches. These start to resemble reported "normal" reactions minus the special situation of the left leg. Pain while deeply inhaling, exhaling or bending increasing. Fatigue - partly from poor sleep. Thur. 3-4-21 Day 7: Still with strong muscle or lung pain, especially upper back. Painful to pull back shoulders. Periodic sharp pain in upper left inner arm, not at injection site. Still pain with deep exhale or inhale. Tried a short walk: After 200 feet, left calf tightening up and pain increasing in both hips. A short rest would clear it but would return with exercise. Lower back pain as well but some of that is pre-existing. Basic circle of pain around rib cage. Skin (or deeper tissue?) on my upper back still very sensitive, resembling sunburn. Produces chills when touched. Sleep still nearly impossible. No sleep aids being used. Fatigue, some headache and chills remain. During this period, I have resorted to pain relievers only twice in order to learn the nature of the symptoms. Fri. 3-5-21 Day 8 During this reaction period: NO fever, nausea, diarrhea, loss of taste / smell, sore throat, congestion or runny nose. Headache, chills, joint & ribcage pain remain. Skin hypersensitive on my upper back. Symptoms today same as on 3-4-21. Moderate morning headache. On a 1.5 mile walk, slight improvement with the left calf muscle cramping. Occasional "clearing" cough, small amount of clear phlegm produced.

"I had pain in the middle of my back an every time I tried to take a breath it would hurt like a broken rib."

First day - resting heart rate 30 -35 beats above normal and blood pressure was up / aching in chest and shortness of breath / Second day - Chills and aching all over

Received 2nd dose of Pfizer COVID vaccine on 2/24/21. No reported adverse reaction at that time. On 3/10/21, developed worsening of chronic back pain. On day of event, took a dose of celecoxib and rivaroxaban (concurrently). He had been avoiding taken chronic celecoxib since at least the time of his last COVID-19 vaccination, and potentially took this fairly rarely due to concern for interaction with his DOAC. Beginning about 5 minutes after these medicaions were taken, patient felt weak/strange and asked his wife to take him to ED. In ED he was initially somnolent but arousable, but then developed hypotension and hypoxemia. Given IV benadryl initially, but then acutely worsened with development of facial, hand, and neck swelling. Reportedly had substantial "frothing at the mouth." Treated with SQ epinephrine, IV methylprednisolone, IV famotidine and was intubated with difficulty. Started on an epinephrine infusion due to persistent hypotension (dose up to 0.1 mcg/kg/min) and transferred to referral center ICU (reporting center). On arrival here, notable hand edema, some facial edema. Ventilator support rapidly weaned to minimal settings. Evaluation and hospitalization ongoing. Overall clinical assessment is anaphylactic reaction to celecoxib unrelated to COVID-19 vaccination.

Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus

Patient received the vaccine around 10 am on 3-10-21. He mentioned to the vaccinator that he had a large anxiety of needles. After receiving the vaccine the patient went to the recovery area for the required 15 minutes. About 10 minutes later his breathing rapidly increased - eventually turning to large gasps of air. The patient then briefly passed out but then quickly woke up. He then started vomiting for the next 10 minutes. Eventually he recovered enough to walk with the help of his wife. The wife stated that he has had episodes like this from other vaccines and blood draws. He has never vomited from the episodes, however.

After receiving the injection, the patient became unresponsive and diaphoretic. His pulse was tachycardic and thready, performed sternal rub without response. RN's noted that pt was not breathing. 9-1-1 called. Pt moved to floor in preparation for CPR, where pt took several deep breaths. Placed pt on his left side, awaiting for arrival of EMS. Gave a tube of gel icing (glucose). Pt slowly started to regain consciousness. EMS on scene. Pt assisted to sitting position and lifted into chair. Pt then transferred to gurney and transported to Hospital for follow up.

Lightheadedness Shortness of Breath near syncope, Very sleepy 4 trips to ER at 2 different hospitals. One admission for 2 days and one admission for 5 days Symptoms still appearing upon discharge

Fevers, chills, body aches and pains for several days starting around 3/10, hospital ER on 3/14 Pneumonia got an antibiotic shot plus zpack 3/17 still not better saw primary care labs done 3/18 More medications given including inhaler Coughing /wheezing Negative covid

Pt admitted 3/22/21 with several week history of Chest congestion, cough, fever, shortness of breath. Had COVID vaccine just before started having symptoms. Decline in respiratory status requiring high flow O2 delivery and admission to ICU for monitoring.

The night of the vaccine administration, begin high fever, shortness of breath, progressing to cardiopulmonary effusions with pneumonia. Continues 1 month later with extreme fatigue, fevers and shortness of breath, systemic muscular pain.

foot became paralyzed; a deep gripping pain in the diaphragm area; leg experienced increasing pain/increasing pain from foot; increasing pain from foot to hip; left foot grew completely numb; Breathing labored; Weakness in left leg; Cramping of calf muscle; chest cavity pain/chest pains left side; ribcage pain; Chills; headaches; Skin hypersensitive on my upper back; back sensitivity; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 71-years-old, administered in Arm Left on 26Feb2021 13:00 (Lot Number: EN6202) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient received 2nd Shingrix vaccination on 24Jan2021. The patient experienced "foot became paralyzed", "a deep gripping pain in the diaphragm area", "leg experienced increasing pain", "increasing pain from foot to hip", "left foot grew completely numb", "breathing labored", "weakness in left leg", "cramping of calf muscle", "chest cavity pain", "ribcage pain", chills, headaches on 26Feb2021 13:45. The patient also experienced "skin hypersensitive on my upper back" and "back sensitivity" on 2021. The patient reported that, "There were no immediate reactions during the 15 minute wait period. Forty-five (45) minutes after my injection I was hit with a rush of side effects. The first was a deep gripping pain in the diaphragm area. While seated, my left leg experienced increasing pain from foot to hip. In short order, my left foot grew completely numb and this extended up my calf to my knee. My foot became paralyzed. The intense leg pain remained steady. Breathing labored. The left foot and calf numbing and paralysis finally subsided 4.5 hours after injection. Saturday through Wednesday, 28Feb to 03Mar2021: Weakness in left leg. Cramping of calf muscle. The chest cavity pain began to intensify. Chills arrive plus daily headaches. During this reaction period: NO fever, nausea, diarrhea, loss of taste / smell, sore throat, congestion or runny nose. Headache, chills, joint & ribcage pain remain. Skin hypersensitive on my upper back. 15Mar2021: Day 17: Chest pains left side, mild headache and some back sensitivity with chills remain." The adverse event started on 26Feb2021 02:30 AM (as reported). Adverse events did not result in either emergency room visit or physician office visit. No treatment received for events. The outcome of the events "foot became paralyzed" and "left foot grew completely numb" was recovered on 26Feb2021 17:30 (left foot and calf numbing and paralysis finally subsided 4.5 hours after injection) while for other events was not recovered. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination (LUMIRADXSARS-COV-2-AG TEST) via nasal swab on 06Mar2021 with negative result. The event "foot became paralyzed" was considered as serious (medically significant).

"Pt had been diagnosed with COVID-19 on 3/28 with onset of cold-like symptoms several days before. He was doing better around the time of his diagnosis and then symptoms progressed in the past few days. Developed significant dyspnea with speaking, ambulating. Requiring cold flow O2."

Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family.

taken to hospital, stayed 7 days, diagnosed with heart removed significant water, released and feeling well at home. i nearly passed out at doctor's office when it was decided to have an ambulance take me to nearby Medical Center where i was admitted and treated for 7 days. the diagnosis was a heart condition with water in my lungs. i never lost consciousness. was treated at night with a CPAC device and was told by the heart,lung and kidney doctor that i made significant progress each day. However, no one could explain after 70 years of no serious (flu) sickness that something suddenly caused my system to fail. At first i thought it might be a function of the COVID shot #2, and it may be.

Minutes after receiving vaccine, patient slumped over and was unresponsive. He appeared to stop breathing, was diaphoretic, and very pale. Four people eased patient to the floor. Once on the floor, the patient snorted and appeared to be breathing, His pulse was tachycardic and thready. Unable to obtain a blood pressure. 911 was called. Patient opened his eyes but was still unresponsive to verbal commands. Patient given a tube of icing (glucose) as his wife could not report when he had last eaten. Slowly, he began to come around. When EMS arrived, patient was assisted to sitting position and then onto gurney. Vitals signs were obtained and reported to be WNL. EMS spoke with patient and wife and convinced patient to be evaluated at ER.

Hospitalized with Pulmonary Thrombosis in both lungs. This occurred approximately 3 weeks after second injection. I had difficulty breathing so admitted myself to Hospital

fast respirations/to every 1 of her respirations, he would take 3 breaths; Chills; was so cold that his fingertips were blue; Fever (103.2 degrees); lost the ability to walk and needed a wheelchair; needed help getting him in and out of bed; conscious but was not responding to commands and was staring at space; conscious but was not responding to commands and was staring at space; This is a spontaneous report from a contactable other healthcare professional (patient's wife). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533), intramuscular administered in the right arm, on 06Apr2021 12:00, as single dose, for COVID-19 immunisation, at a clinic. Medical history included dementia (frontotemporal dementia, behavior variant) from Jun2010 and ongoing, could not speak, hypothyroidism, prostate and urinary problems, and COVID-19 in Dec2020. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 2020 and ongoing; and morniflumate (FLOMAX tablet 4 mg) taken for prostate and urinary problems from an unspecified date (reported as 5 or more years) and ongoing. The patient did not have prior vaccinations (within 4 weeks). On 06Apr2021 at 17:00, 5 hours after the vaccination, the patient experienced fever (103.2 degrees), lost the ability to walk and needed a wheelchair, needed help getting him in and out of bed, conscious but was not responding to commands and was staring at space, chills, and was so cold that his fingertips were blue. On 07Apr2021, the patient experienced fast respirations/to every 1 of her respirations, he would take 3 breaths. The reporter further explained that the patient experienced chills, fever, lost the lability to walk and needed a wheelchair, and needed help getting help in and out of bed. She stated he was unresponsive but clarified that he was conscious but was not responding to commands and was staring at space. The chills lasted for less than an hour. She put a heating blanket on him. She added that he was so cold that his fingertips were blue. The chills ended and he ran into a fever which lasted for 10 hours. She mentioned that if his fever would have been greater than 105 degrees, she would have sent him to the emergency room. The highest it reached was 103.2 degrees. She gave him Tylenol and cold compresses which brought his temperature down to 101. He was comfortable. Initially, on an unspecified date, his breathing, color and blood pressure were all good. While he had a fever, she observed that to every 1 of her respirations, he would take 3 breaths. From a cardiovascular view he is healthy. The local paramedics come and check on him periodically and the reporter monitors his glucose and blood pressure (unknown results). She stated that all of these were complicated by him having dementia. The reporter stated that he was getting better. She was not panicked and was not complaining. She wanted the officials to know that she thinks people who have had Covid should be tested to see the level of antibodies present or a titer test before having the vaccine and that maybe they not need the vaccine. The events did not require visits to emergency room and physician's office. The reporter assessed the events "Fever (103.2 degrees)", "lost the ability to walk and needed a wheelchair", "needed help getting him in and out of bed", "conscious but was not responding to commands and was staring at space", "fast respirations/to every 1 of her respirations, he would take 3 breaths" as serious (medically significant). The patient recovered from chills on 06Apr2021 (after less than an hour), "Fever (103.2 degrees)" on 07Apr2021 03:00, "fast respirations/to every 1 of her respirations, he would take 3 breaths" on 07Apr2021, "conscious but was not responding to commands and was staring at space" on 12Apr2021; recovered with sequel from "lost the ability to walk and needed a wheelchair", "needed help getting him in and out of bed" on 09Apr2021; and was recovering from "was so cold that his fingertips were blue".; Sender's Comments: Based from know drug safety profile and sequence of events, the reported events in relation to suspected drug BNT162B2 cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

difficulty breathing; low oxygen blood level; potassium level increased; extra fluid in his body; shivering and quaking and chills; nauseous and vomiting; nauseous and vomiting; Panic attack; was freaking out; soft pain in left side of chest; fast pulse; This is a spontaneous report from a contactable consumer (Patient's wife) A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151) on 10Apr2021 at 17:00 at single dose via an unspecified route of administration on arm right for COVID-19 immunization. It was informed that patient had vaccination on right arm because he had a dialysis fistula in his left arm. Relevant medical history included also ongoing End stage renal disease, dialysis on 13Apr2021. The patient received first dose of BNT162B2 (lot number: EP6955) and experienced arm pain and headache. Concomitant medications were not reported. On 11Apr2021 the patient experienced shivering and quaking and chills, nauseous and vomiting, panic attack, 'was freaking out', soft pain in left side of chest, fast pulse , all provided as non serious. On the same day 11Apr2021 the patient also experienced difficulty breathing, low oxygen blood level, potassium level increased and extra fluid in his body which led to the emergency room and admission to the hospital. Clinical course was described as follows: everything was going good until Sunday at 3:29 am. Her husband woke up shivering, quaking, and he was freaking out repeating oh my god, so she called emergency number. When her husband found out that she couldn't get into the ambulance with her husband and ride to the hospital, so her husband refused to go to the hospital. She states that her husband also felt nauseous and vomited in this period of time. She stated that he had no fever, though. So fast forward to 8:30 am her husband was having difficulty breathing, and she called again and this time they had 7 paramedics come out to the house. She states that all of them were very nice. An EKG was performed because patient reported that he had a soft pain in his left side of his chest. She states that everything was cool with that, except his pulse rate was high. She states that he also had low blood oxygen level. She states that they strapped in her husband in and drove him to the hospital to the ER. At the ER they discovered that potassium level increased and she said that he had some extra fluid in his body. He was a dialyses patient so they gave him dialysis on Sunday evening. He had calmed down at that point and they were constantly taking blood from him. She found out about the COVID vaccine had potassium and phosphate as active ingredients and her husband shouldn't have that. She also informed that they had to give him a tranquilizer because he was having a panic attack during this whole episode. She says that they gave him alprazolam. Patient doesn't know exactly when the side effects went away because he didn't have a clock or a phone. Patient's wife also clarified that he vomited twice before going to the hospital but then he felt like he had to vomit afterwards but he did not. She stated that his breathing problems didn't stop when paramedics came and gave him oxygen. They made it to their house by 8:40 am, and he still had low oxygen level, they were still giving oxygen the whole time he was in the hospital. The patient was discharged on 13Apr2021. At the time of the reporting event outcome was unknown.

chest was horribly over expanded/ chest that was hyperinflated; patient had the first dose on 14Feb2021 and the second dose on 01Mar2021; patient had the first dose on 14Feb2021 and the second dose on 01Mar2021; Worse breathlessness/shortness of breath; Vaccine changed the cellular airway phenotype/inflammation in the airway before the vaccine had changes qualitatively or quantitatively; Vaccine changed the cellular airway phenotype/inflammation in the airway before the vaccine had changes qualitatively or quantitatively; Plagued with a cough, some from his upper airway and some from his lower airway; This is a spontaneous report from a contactable physician. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported), at the age of 71 years old, as single dose for COVID-19 immunisation. Medical history included breathlessness (which has been a bit of an issue for 6-8 months), subclinical airway disease, and inflammation in the airway; all are ongoing. The patient stopped smoking years ago. The patient's concomitant medications were not reported. The patient previously had the first dose of BNT162B2 on 14Feb2021 for COVID-19 Immunisation. The physician stated that he was a lung specialist and had a friend (patient) who got the Pfizer vaccine. The patient had the first dose on 14Feb2021 and the second dose on 01Mar2021. Shortly after the second dose, the patient had breathlessness, which has been a bit of an issue for 6-8 months he hadn't seen him with the pandemic, he got worse breathlessness on Mar2021. Stated that they both got vaccinated and he went to his house and the patient said to let himself in as he (patient) had shortness of breath and can't go up and down the stairs. The physician stated that he (physician) was his student but he was also the patient's lung specialist and he was treating him. The patient was then initially treated with Breo which was a combo drug that was good with airway disease. It was a product from GSK that was an inhaled steroid and long acting. It worked 72-96 hours and he was really trapping a lot of air and feeling it in his back musculature. Stated that the patient stopped taking it and mentioned that the patient was a guy and guys are sort of born stupid and he never called him and found out he was plateauing and not better. The patient was then started on Anoro which was 2 drugs in one an anticholinergic and a long acting sympathicsomatic and he was considerably better. The patient was still plagued with a cough, some from his upper airway and some from his lower airway in Mar2021. The physician said that he had to be careful with inhaled steroids because the patient does not want to weaken his vocal cords. The physician then stated what he thought happened was the vaccine changed the cellular airway phenotype and that happened since the patient was vaccinated with the second dose. Stated that the inflammation in the airway before the vaccine had changes qualitatively or quantitatively or both and what the vaccine does was recruit all sorts of inflammation and sorts and distributes it through the body. The physician was asking to get guidance with regards to pharmacology and even more complicated think beta 2 receptors polymorphism which means unlike him (the physician), who was asthmatic can reach for his rescue inhaler and get better if he needed to and the patient can't do that, he had to be on a category of medication reserved for emphysema or chronic bronchitis which he does not have. Stated he will formulate a question on what was the airway phenotype before the vaccine going on with it, in retrospect brewing for away and some tipping point was reached and something happened with the vaccine, which he felt was excellent in clinical. The physician stated that the immune response in the airway was a large response, stating that there were 1000 cell types and a million chemicals in that "soup". The physician stated that he would like a call next week and talk to a Pfizer pulmonologist and get guidance and a little instruction the patient does not want to damage his airway. Stated 8/10 times the airway issue resolves with Breo and 2/10 times it doesn't. Stated that this situation got worse after vaccinated and paradoxically they got together after 6-8 months to see each other. Stated that the medication was Breo 100 and what was happening was the patient was trapping a lot of air and he measured his total lung volume and his chest was horribly over expanded. Stated that the patient's total lung volume on 18Mar2021 was 160% the predicted and that it was the equivalent of taking the normal lung volume, 4L and putting in another 2.5L and walking around with a chest that was hyperinflated and when the patient reaches to take a breath there was no room. The physician stated he has taken care of him and the patient "plateaued" and he needed to do something. The outcome of cough was not recovered, while outcome of the remaining events was unknown. No follow up attempts are needed; information about lot/batch number cannot be obtained.

Awoke unable to breathe, severe weight in right lung. Called Clinic, advised to go to ER at Hospital. Chest CT showed multiple pulmonary embolli in both lungs- placed on Eliquis. 19 days later had severe nausea, vomiting, fainting. Clinic nurse again advised going to ER where cerebral hemorrhage was diagnosed. Patient life flighted to Hospital . Eliquis discontinued, Keppra started to prevent seizures. In ICU 4/26-28, released to home.

Pfizer-BioNTech COVID-19 Vaccine EUA: in clinic visit immediately following vaccination patient reports eyes watering, redness on face, throat swelling. Vital signs all within normal ranges. Provider noticed swelling of soft tissue around eyes and cheeks. On physical exam no hoarseness noted; lungs clear without wheezing, rhonchi, or rales. Administered diphenhydramine in clinic and advised to continue at home and referred to allergy/immunology clinic for follow-up.

After 07 (seven days) of 2nd vaccine i.e. from January 29Jan2021 night my frequent nasal congestion; breathing problem; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 71-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: PFIZER EL3248) via an unspecified route of administration in left arm on 22Jan2021 at 11:00 as single dose for COVID-19 immunization. Medical history included blood pressure and cervical spondylitis. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not diagnosed with COVID-19. Patient's allergies were not known. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: PFIZER 3756) via an unspecified route of administration in left arm on 01Jan2021 at 11:00. On 29Jan2021, at night (after seven days of vaccine), the patient experienced frequent nasal congestion and breathing problem and it was still continuing even after three weeks of vaccination. On 17Feb2021, the patient was tested for SARS-CoV-2 Semi-Quant Total Ab; test results showed SARS-CoV-2 Semi-Quant Total Ab greater than 250.00 Abnormal i.e. antibody level was abnormally very high (normal less than 0.8 U/ml). Patient wanted to know if patient's nasal congestion and breathing problem was due to abnormally very high level of antibody, developed after Pfizer Covid-19 vaccination and if so, how long it would continue and what measures/precaution/remedies patient could take to reduce side effects. On 17Feb2021, patient also mentioned that oxygen level in oximeter and chest ray were ok. Outcome of the events was not recovered.

Patient presented to Hospital emergency room on 5/10/2021 with shortness of breath and dizziness. He had tested for Covid on 5/9/2021 for a pre procedure for a pulmonary function test. It is stated that he feels slightly short of breath chronically at baseline. Patient also notes occasional dizziness. No other symptoms.

Patient reported to the ED 3 days after vaccination with shortness of breath and chest pain. ST elevation noted and sent to cath lab, CT angio revealed that he could have a small subsegmental pulmonary embolism.

Shortness of breath, spitting up blood, heart stopped and unable to resuscitate. All happened within a 20-minute time. No chest pains.

COUGH, HEADACHES,FATIGUE Pneumonia due to COVID-19 virus HOSPITAL COURSE Admitting Diagnosis: Altered mental status, unspecified altered mental status type [R41.82] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course (2 Days) YOU presented with fever, nausea, altered mental status, generalized body aches and incontinence of stool, the symptoms of which came on after he received his 2nd Covid vaccine yesterday. Per report of the patient's daughter, he received his 1st Covid vaccination approximately 21 days ago. Ten days ago he tested positive for COVID-19. Despite this, the patient was instructed to proceed with securing a 2nd Covid vaccination after which his symptoms came on. Upon presentation here, the patient was noted to be quite febrile to a temperature of a 103.2°. On diagnostic workup, he did have a chest x-ray done which demonstrated vascular and alveolar congestion. Fluid overload or cardiac decompensation. No other suspicious acute abnormality identified. NO CHF HAS COVID It is not recommended to take the covid vaccine within 30 days of covid infection due to increasing infammation and symptoms and should have immunity for at least 90 days from the infection with covid We did walk you and you do not require any oxygen .

felt unwell; took his oxygen level and it was at 80%; he had swelling; difficulty breathing; tachycardia; allergic reaction; tested Covid-19 positive; blood clots; he got very sick; This is a spontaneous report from a contactable consumer(patient's daughter). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) at the age of 71-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fine and nothing happened until after the vaccine. The patient took the 1st dose on 24Apr2021 and the next day he got very sick, they thought it was just a reaction from the vaccine, then he was swelling said he was not feeling well. The day after the vaccine, the patient was rushed to the emergency room and confined to the ICU. He felt unwell and it got worse and worse, we took his oxygen level and it was at 80%, he had swelling, difficulty breathing and tachycardia. The reporter thought it was an allergic reaction but this morning the patient tested positive for covid, he didn't go out the only time he went out was to get the vaccine. The reporter asked If he didn't know he had covid and got the vaccine, will he get more sick. In the report they found blood clots and the doctors thought it was from the vaccine. He was diagnosed with blood clots and difficulty breathing and he tested Covid-19 positive. Events seriousness criteria reported as hospitalization. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

ED, Discharged , 3/13/2021 (4 hours), Hospital ED, MD Last attending o Treatment team Shortness of breath +1 more Clinical impression Chest Pain o Shortness of Breath o Dizziness Chief complaint, Patient presents with o Chest Pain, o Shortness of Breath o Dizziness. History of Present Illness , Patient is a 71 yr.. male with Hx of stage IIICM Metastatic Adenocarcinoma of the sigmoid Colon, Coronary disease, Hypertension, Dyslipidemia, Chronic Renal insufficiency, presenting to the ED with chest pain. Patient notes that he woke up this morning with pain in the right side of the chest with some associated shortness of breath. Notes symptoms. Additional information for Item 18: Notes symptoms are worse when he is up trying to exert himself and gets incredibly short of breath and fatigued. States he tried to do some workout in the garage but was unable. Denies chest pain worsening with exertion, but has been fairly constant since it began. Reports it is a dull ache. Pain is dissimilar from his previous heart attack. States he has had a mild cough, but no significant production. Denies any fevers, chills. No abnormal nausea or vomiting other than typical chemo induced side effects. Given continued issues, decided to come in for further evaluation. Review of Systems; Constitutional: Positive for fatigue. Negative for appetite change, chills, diaphoresis and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Positive for cough and shortness of breath. Negative for choking and chest tightness. Cardiovascular: Positive for chest pain. Negative for palpitations and leg swelling. Gastrointestinal: Positive for nausea and vomiting. Negative for abdominal pain and diarrhea. Genitourinary: Negative for dysuria. Musculoskeletal: Negative for back pain and neck pain. Skin: Negative for rash. Neurological: Positive for light-headedness. Negative for seizures, syncope, numbness and headaches. ED to Hosp-Admission, Discharged, 4/5/2021 - 4/25/2021 (20 days) Hospital, MD, Last attending Treatment team Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present. Principal problem Discharge Summary, DO (Physician), Inpatient Discharge Summary; BRIEF OVERVIEW; MD, Discharge Provider: DO, Primary Care Physician at Discharge: MD, Admission Date: 4/5/2021, Discharge Date: 4/25/2021. Discharge Diagnosis; Medical Problems ;Hospital Problems; POA, (Principal) Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present, Yes, Essential hypertension Yes, Chemotherapy-induced peripheral neuropathy, Yes. Overview Signed 5/10/2019 2:03 PM by MD, Pins and needles and numbness in tips of finger and toes, Lung metastasis Yes. Hypoxia Yes. COVID-19 Unknown, Acute respiratory failure with hypoxia Yes, Palliative care encounter Not Applicable, Declining functional status No. DETAILS OF HOSPITAL STAY; Presenting Problem/History of Present Illness/Reason for Admission, Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present. Acute hypoxemic respiratory failure due to COVID-19,Respiratory failure. Sigmoid perforation with abscess. Hospital Course; 71-year-old male prolonged admission for acute hypoxic respiratory failure secondary to COVID-19. No history of colorectal adenocarcinoma with lung mets. Prior resection of bowel, prior chemotherapy. Required management in the ICU due to worsening respiratory failure over the time that he has been admitted to Hospital (20 days). He had remained on BiPAP therapy throughout that time, received appropriate corticosteroids, and antiviral therapies. Approximately 1-1/2 weeks ago he began to develop mild left lower quadrant abdominal pain. In the last 48 hours this is significantly worsened. CT abdomen and pelvis was obtained on Friday, which displayed pneumoperitoneum, sigmoid abscess with sigmoid perforation. There is a prior anastomotic site distal to this. Given his overall complexity he was to be medically managed to avoid the need for OR and intubation. He did well through the initial 24 hours of IV antibiotics, fluids and bowel rest. This afternoon he became increasingly dyspneic, required implementing nonrebreather mask, and subsequently developed severe rigors, tachycardia. I obtained a stat follow-up CT scan which shows similar findings of free air within the abdomen. Given signs of impending sepsis, BiPAP therapy was initiated, bolus IV fluids were given. Blood gas, blood counts, lactic acid are pending. He is receiving empiric Zosyn. I discussed this with general surgery, whom is well-known to the patient. In agreement the patient likely needs surgical intervention. However given his overall complexity and in light of the fact that this area surrounds the ureter, and we do not have urology coverage. It was felt he was most appropriate to be managed in Hospital. Case was discussed with Dr. at Hospital, patient will be transferred there via air transit. At this time his blood pressure appears stable, he is tachycardia, is currently on BiPAP which will be transitioned to CPAP for transport. He has received several doses of Dilaudid, for improved pain control. No further advancement of airway was performed prior to discharge. Case was discussed with family at length, all risks and benefits of transfer were discussed with wife and patient. It is recommended to involve pulmonary critical care services including surgical ICU care as if requiring surgery he is high likelihood for prolonged vent needs. Operative Procedures Performed Treatments: See above; Procedures: Na Consults: pulmonary/intensive care and general surgery. Pertinent Test Results: CT abdomen pelvis with contrast [3279871876] (Abnormal) Resulted: 04/25/21 1811. Order Status: Completed Updated: 04/25/21 1812. Narrative: PROCEDURE INFORMATION: Exam: CT Abdomen And Pelvis With Contrast, Exam date and time: 4/25/2021 17:36, Age: 71 years old, Clinical indication: Abdominal pain; Additional info: Sepsis, bowel perf. HX of Covid19 +, malignant colon with lung metastasis. Bowel perf. TECHNIQUE: Imaging protocol: Computed tomography of the abdomen and pelvis with contrast. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. Contrast material: 350 OMNI; Contrast volume: 80 ml; Contrast route: INTRAVENOUS (IV); COMPARISON: CT ABDOMEN PELVIS W CONTRAST 4/23/2021 16:46, FINDINGS: Tubes, catheters and devices: Catheter terminates in the right atrium in satisfactory position. Lungs: Moderate airspace opacities throughout the lung bases are similar to prior and consistent with Multilobar pneumonia consistent with the history. Liver: No hepatic masses. Gallbladder and bile ducts: Cholelithiasis. Pancreas: No ductal dilation. No masses. Spleen: No splenomegaly or focal lesions. Adrenal glands: No mass. Kidneys and ureters: 10 mm benign left renal cyst, no follow-up necessary. No renal masses or Hydronephrosis bilaterally. Stomach and bowel: Redemonstration of perforated proximal sigmoid diverticulitis. Small pneumoperitoneum is stable. Predominantly gas containing, 25 x 28 mm collection adjacent to the inflamed sigmoid colon similar to prior; a fistulous tract extends toward the midline containing gas and fluid, with suspected fistula to adjacent loops of small bowel. Moderate to severe descending and sigmoid diverticular burden. Minor right diverticular burden. No small bowel obstruction. A somewhat clumped appearance of small bowel in the right lower quadrant near the colon enteric fistula. Appendix: No evidence of appendicitis. Intraperitoneal space: Mesenteric edema around the small bowel, slightly increased, however no new mesenteric collection. There is no extravasation of enteric contrast into the collection adjacent to the sigmoid colon. Vasculature: Mild aortoiliac atherosclerosis. Lymph nodes: No significantly enlarged lymph nodes. Urinary bladder: Unremarkable as visualized. Reproductive: Unremarkable as visualized. Bones/joints: Degenerative changes in the spine. Multilevel disc space narrowing. Multilevel central canal and neuroforaminal stenosis in the lumbar spine. No acute fracture or subluxation. Soft tissues: Small fat-containing right inguinal hernia. Small fat-containing left inguinal hernia. Large ventral abdominal hernia containing gas, which has replaced the previous contents of fat and bowel loops. Volume increased compared to prior. IMPRESSION: 1. Redemonstration of perforated proximal sigmoid diverticulitis. Small pneumoperitoneum is stable. 2. Similar perisigmoid collection; colon enteric fistula, probably at least subacute in duration. The perisigmoid collection is prominently gaseous and there is no frank abscess. 3. Suspected mild enteritis the small bowel loops or loops associated with the fistula. No obstruction. 4. Additional findings as described are similar to recent prior imaging. COMMENTS: Any incidental renal lesion less than 1 cm or classified as too small to characterize, or any incidental cystic renal lesion characterized as simple-appearing, is likely benign. No follow-up imaging is recommended for these lesions per consensus recommendations based on imaging criteria. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD, CT abdomen pelvis with contrast (Abnormal) Resulted: 04/23/21 1804, Order Status: Completed Updated: 04/23/21 1804, Addenda: THIS REPORT CONTAINS FINDINGS THAT MAY BE CRITICAL TO PATIENT CARE. The findings were verbally communicated via telephone conference with RN at 6:03 PM EDT on 4/23/2021. The findings were acknowledged and understood. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD Signed: 04/23/21 1804 by, MD. Narrative: PROCEDURE INFORMATION: Exam: CT Abdomen And Pelvis With Contrast, Exam date and time: 4/23/2021 4:42 PM, Age: 71 years old Clinical indication: Abdominal pain; Localized; Left; Additional info: HX of colon cancer. Worsening left sided abdominal pain. HX of colon cancer. Worsening left sided abdominal pain. TECHNIQUE: Imaging protocol: Computed tomography of the abdomen and pelvis with contrast. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. Contrast material: OMNIPAQUE 350; Contrast volume: 80 ml; Contrast route: INTRAVENOUS (IV); Other contrast: Oral, omnipaque 12mg premixed solution, 500mL pt unable to drink 1000mL; COMPARISON: 1. CT ABDOMEN PELVIS W CONTRAST 2/12/2021 11:06 AM, 2. CT ABDOMEN PELVIS W CONTRAST 11/13/2020 11:42:26 AM, 3. CT ABDOMEN PELVIS W CONTRAST 8/24/2020 10:14:40 AM, FINDINGS: Lungs: Bilateral lower lung consolidation. Liver: No mass. Gallbladder and bile ducts: Cholelithiasis, no biliary ductal dilatation. Pancreas: Normal. No ductal dilation. Spleen: Normal. No splenomegaly. Adrenal glands: Normal. No mass. Kidneys and ureters: Normal. No hydronephrosis. Stomach and bowel: Collection of fluid and gas adjacent to the proximal sigmoid colon where there are multiple diverticuli, extraluminal gas arises from a proximal sigmoid perforation which is proximal to the sigmoid anastomosis. No bowel obstruction, no wall thickening at the anastomosis. Appendix: No evidence of appendicitis. Intraperitoneal space: Pneumoperitoneum. Small collection of fluid and gas in the left pelvis and left lower abdomen, maximum short axis diameter approximately 2 cm, arising from the proximal sigmoid colon. Vasculature: No abdominal aortic aneurysm. Lymph nodes: No significant adenopathy. Urinary bladder: Unremarkable as visualized. Reproductive: Unremarkable as visualized. Bones/joints: No acute findings. Soft tissues: Ventral hernia containing bowel without entrapment. IMPRESSION: Perforated diverticulitis, small pericolonic abscess; the sigmoid perforation is proximal to the sigmoid anastomosis. Physical Exam at Discharge; Heart Rate: (!) 131,Resp: (!) 42, BP: (!) 168/92 Temperature: 37.1 °C (98.7 °F) Weight: 107 kg (236 lb. 12.4 oz.), General appearance: alert, appears stated age, cooperative, severe distress and morbidly obese, Head: Normocephalic, without obvious abnormality, atraumatic, Neck: supple, symmetrical, trachea midline and thyroid not enlarged, symmetric, no tenderness/mass/nodules. Lungs: retractions and diminished breath sounds Heart: tachycardia, RR. Abdomen: Distended significantly tender in the left lower quadrant with guarding throughout. Extremities: Trace pretibial, Skin: Skin color, texture, turgor normal. No rashes or lesions or Ecchymosis areas throughout upper extremities. Neurologic: Alert and oriented X 3, no focal deficit. Discharge Instructions; Condition at Discharge, Discharge Condition: critical. Admission, Discharged 4/25/2021 - 5/1/2021 (6 days) Hospital, MD, Last attending Treatment team Respiratory failure, acute. Principal problem, Discharge Summary MD (Resident) Cosigned by: MD at 5/18/2021 1:24 PM; Final Summary for Deceased Patient, BRIEF OVERVIEW; Admitting Provider: MD; Discharge Provider: MD Primary Care Physician at Discharge: MD Admission Date: 4/25/2021, Discharge Date: 5/1/2021, Final Diagnosis, Principal Problem: Respiratory failure, acute. Active Problems: Malignant neoplasm of sigmoid colon. Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present COVID-19. Perforated viscus. DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Respiratory failure, acute, Hospital Course; Patient is a 71 yr.. male with history of metastatic colorectal adenocarcinoma with lung metastases, prior bowel resection and chemotherapy. The patient initially tested positive for Covid in early March. His symptoms at that time are mild and resolved. He was later vaccinated and that month. He started having severe symptoms again on 4/3 for which he presented to Hospital. Since that time, he has received full course of Remdesivir and steroids. He had a CT scan performed on 4/23 which revealed pneumoperitoneum secondary to presumed perforated sigmoid diverticulitis with focal sigmoid abscess. Patient was weaned down to minimal nasal cannula settings but somewhat suddenly earlier on 4/25 patient had increased work of breathing, became tachycardia, and had rigors. Hospital ordered repeat CT scan which showed similar findings in the abdomen. Patient had been maintained on Zosyn. Repeat labs were sent which were largely unremarkable. Given concerns for worsening sepsis and potential need for surgery, he was subsequently transferred Hospital. On admission to hospital, he had a normal lactic acid and no leukocytosis. He did not have evidence of peritonitis. The decision was made to treat his diverticulitis conservatively. However, early on 4/26 the patient started to develop a lactic acidosis. An extensive discussion was had with the patient and his wife regarding surgery and the possibility the patient may never be able to separate from the vent given his worsening Covid pneumonia. The patient elected to undergo an exploratory laparotomy with with segmental resection of distal descending and loop transverse colostomy. However, as the days progressed the patient had worsening respiratory status that required deep sedation, paralytics and proning all of which were unsuccessful in maintaining his oxygen saturation greater than 88%. His wife, knowing that he would not want to have a prolonged course on the ventilator, elected for transition to palliative extubating with comfort care on 4/30 and the patient expired roughly 10 minutes after extubation.

A few days after the second Covid shot I started having chest pains, shortness of breath, dizziness after just just walking or mild exercise . This persisted fir a couple days until I went to a heart doctor had PET test , went to heart hospital for angiogram and had a stint placed into LAD heart artery on March 29. I am still having chest pains and shortness of breath. But not as severe as before the stint was put in artery. Before I had the second Covid shot I could exercise hard with no ill effects. After Covid shot I could barley walk 50 yards without severe chest pains etc.

I developed acute asthma symptoms, including severe shortness of breath upon any kind of exertion. Also a lingering cough that hasn?t gone away.

Brief periods of shortness of breath, each lasting 2 to 5 minutes. Also had small sharp pain in right calf, lasting 10 minutes. Wasn't severe, so no Dr called.

After 1st Shot 4/13/2021 - minor arm pain, then about 3rd week breathlessness and cough, Doctor prescribed Albuterol Sulfate inhalation Aerosol and Benzonatate capsules which relieved the symptoms; After 2nd Shot 5/4/2021 - minor arm pain, followed by more breathlessness and cough and severe and painful cramps in left calves and left hand; these symptoms came and went every other day or 2 through 5/22/2021 when they became severe and I sought medical help from Urgent care 5/26/2021. Referral to Emergency Room - diagnosis Hypertension/Heart Failure. Symptoms occur every other day or 2, additional symptoms severe shivering followed by uncontrollable shaking of right arm and leg and prior symptoms severe

Initially just extreme tiredness, which over a 2-7 week period progressed to also include a significantly debilitating level of breathlessness and high heart rate during strenuous activity. More recently, this appears to have resolved in large part.

flu; felt like he was back having the COVID-19 virus all over again; Urine was a bright yellow color; soaking wet sweating; fever of 101; tiredness; headaches; chills; He slept the whole day; joints; shortness of breath; weakness; lower back was hurting; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/ Lot number: On CDC vaccine record card reporter thinks Lot is EN6206, pretty sure but could be EV6206) (pending for clarification), via an unspecified route of administration on 15Mar2021 (reported as Monday) (at the age of 71-year-old) at around13:00-13:30, at a single dose for COVID-19 immunization in clinic. Patient had a history of COVID-19 virus around onset about the last day of Sep2020 or Oct2020.Down and out for about 14 days before totally turned it around (when he had COVID-19 virus they turned him away from his normal doctor and told him to go get tested on his own so the whole process was handled through emergency urgent care testing) and had a blood disorder, does get blood clotting. The patient had no relevant concomitant products or other medical conditions. Nothing relevant; he has just been taking the medicines he has always taken; mostly a lot of vitamins and stuff and he takes a full acetylsalicylic acid (ASPIRIN). Patient had his last blood work and testing done in Oct2020 when they gave him clearance, told him he was no longer positive for COVID-19 virus, no bloodwork taken since then. Patient had undergone height measurement and resulted as 5 feet, 9 inches, probably 5 feet, 8 inches because he shrunk getting older but thinks 5 feet, 9 inches. Patient had no exposure that he was aware of other than his own history of COVID-19. He went and asked if he should get the Pfizer-BioNTech COVID-19 Vaccine and was told yes because it was over 90 days since he was cleared of COVID-19. On 15Mar2021, patient had some issues with first shot. After his vaccine by the end of the day he felt like he was back having the COVID-19 virus all over again and had all the symptoms he had before, like weakness, shortness of breath and everything. He stated he was really got effected at the end of the evening but did not know until the following morning when he woke up and was soaking wet sweating and had a fever of 101. He slept the whole day and by the end of the second day he felt much better but still had a fever. He sweat that evening and the next morning felt good again. This all lasted a total of maybe 24 hours until he felt good again. He had something different after the Pfizer-BioNTech COVID-19 Vaccine that he did not have when he had COVID-19 virus which was his urine was a bright yellow color from 16Mar2021 to 17Mar2021. His urine looks normal again today (18Mar2021), but he did not have urine symptom when he had COVID-19 virus previously. Patient reported that he had the flu on an unspecified date. He asked because he is slated for the second dose of the Pfizer-BioNTech COVID-19 Vaccine on 08Apr2021, he stated he knows the first shot was supposed to give him 50 percent immunity, he does not think he should go do it again, it makes him real nervous about the results he had from the first dose of Pfizer-BioNTech COVID-19 Vaccine; asked if he should or should not get the second dose relative to these events. Everyone else said it was a piece of cake, but it wasn't for him. He was ok all day after the Pfizer-BioNTech COVID-19 Vaccine was administered 15Mar2021, felt pretty decent the rest of the day and evening. On 16Mar2021 his whole world changed, felt like he was back having the COVID-19 virus all over again starting 16Mar2021 he had exactly all the same things, feeling like he had before, that he experienced when he had COVID-19. He woke in the middle of the night with sweats, really hot-his wife took his body temperature, and his body temperature was 101; he slept most of the day on 16Mar2021. He had tiredness; headaches; chills; joints; fevers; the whole thing for about a 24 hour period until event finally subsided, clarified as improved the patient was started feeling a little better 16Mar2021, but he sweat like crazy that evening so that must have broken the fever. It was not until morning of 17Mar2021 that he felt functional. He still once in a while gets a little headache but that is minor. The only thing was on the second day after the first dose of the Pfizer-BioNTech COVID-19 Vaccine was administered, after events onset, patient received a couple of Aspirin because his lower back was hurting, probably from sitting so long. The reporter assessed the events as non serious. The outcome of the events urine was a bright yellow color was recovered on 18Mar2021, lower back was hurting was unknown and the rest of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient was experiencing cold symptoms, with symptom onset about 10 days before he fell very ill, on 5-30-2021. His wife called EMS, and he was taken to the ER and then admitted to the Hospital on 5-30-2021 experiencing generalized weakness, confusion and having suffered a fall in his home. Upon admission, he was in respiratory distress. His medical records indicate Acute Hypoxemic Respiratory failure and COVID19 Pneumonia. He passed away on 06-01-2021.

chills; uncontrollably shakes; nauseous; fatigue; That night started to vomit; fever (101 degree temp); shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 17:00 (Batch/Lot Number: EN5138) as SINGLE DOSE for covid-19 immunisation. Medical history included heart Cond, RA (Rheumatoid arthritis) and allergies. The patient's concomitant medications included unspecified medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. First shot on 2/9 at 5pm. 24 hours later on 10Feb2021 05:00 PM chills, fever (101 degree temp), shortness of breath, uncontrollably shakes, nauseous, fatigue. Symptoms continued for the next 48 hrs and went to the local clinic. The patient was tested for covid and the flu. Both were negative. Prescribed nausea med. That night started to vomit and continued for the next 50 hours off and on. Fever broke at around 9 am on 2/15. The patient visited to emergency room/department or urgent care. Therapeutic measures were taken as a result of events. The outcome of the events were recovered on 2021.

First episode Feb 18 (16 days after first Covid vaccine): fainting, shortness of breath at onset of light exercise (called Dr., advised to drink more water). Second episode: Feb. 23, one day after second Covid-19 shot: inflamed left calf, redness of skin. Dr. and ER visit Feb. 24, diagnosed with critical DVT and multiple pulmonary embolisms. ER put me on heparin IV drip, Overnight stay in hospital, discharged with Eliquis blood thinner prescription. Continuing that med for life, per hematologist

Patient has a lot of fatique, vertigo. One evening couldn't make it from the car to the door. Went to sleep. Woke up feeling the same way. Went to ER. Took Covid test, negative. Doctor took x-rays, notice blood clots, admitted for 3 days. Doctor said blood clots were a triggered by an event-Covid. His next appointment is on July 17th. Potential lifetime damage. Patient continuing to feel fatique and shortness of breath.

On May 6, 2021, patients were relatively normal. On June 4th he started complaining of right sided abdominal pain along with increasing generalized weakness/fatigue. On June 10th CT Abdomen/Pelvis ordered by PCP, it was completed on 6/16/21. On 6/17/21 patient started c/o of right flank pain as well as ongoing right abdominal pain, U/A collected, normal results. On 6/22/21 patient contact PCP office c/o acute shortness of breath, chest pain and increased weakness. He was advised to call 9-1-1 and go to the ER. He was transported to local Medical Center and found to have extremely elevated platelet count as well as elevated liver enzymes. He was admitted to the ICU he ultimately succumbed to this acute illness on 6/25/21

Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes

Fever; Tachycardia; Hypotension; acute on chronic hypoxic respiratory failure; acute exacerbation of chronic obstructive pulmonary disease; This is a solicited report from from a contactable physician and other health professional based on the information received by Pfizer (Manufacturer Control No: UNT-2021-009438). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 26Apr2021 (Batch/Lot number was not reported), as dose 1, single, for COVID-19 immunisation; and treprostinil sodium (TYVASO Inhalation gas), via respiratory inhalation, from 08Feb2021 (Batch/Lot Number: 2101925; Expiration Date: 31Jan2022), at 18-54 ug, four times a day, for primary pulmonary arterial hypertension (Pulmonary arterial hypertension). Medical history included pulmonary arterial hypertension, rhinitis allergic, arteriosclerosis coronary artery, coronary artery disease, basal cell carcinoma (cheek), chronic kidney disease, coagulopathy, chronic obstructive pulmonary disease (2 years), diaphragmatic hernia, deep vein thrombosis (after knee surgery; 3 clots in calf of right leg), factor V Leiden carrier, gastrooesophageal reflux disease, nephrolithiasis, essential hypertension, hyperlipidaemia, liver disorder (liver abscess with resection (partial resection in 2007) due to strep infection), osteoarthritis, supraventricular tachycardia, type 2 diabetes mellitus (without complication and without long term current use of insulin), stress (to some extent), benign prostatic hyperplasia, umbilical hernia, arthritis, aortic valve incompetence, aortic disorder, aortic dilatation, iga nephropathy, nephrolithiasis, sleep apnoea syndrome, bicuspid aortic valve, pain, wheezing, prostatomegaly, neck pain, oral disorder, illness, liver abscess, sepsis, transaminases increased, dyspnoea, hydrocele operation, dependence on oxygen therapy, all from unspecified dates and ongoing; neoplasm malignant in 2014 and ongoing; colon operation in 1985; abdominal operation in Feb2007 (Liver resection due to abscess); cholecystectomy in Feb2017; pneumonia bacterial in 2010; coronary angioplasty in May2011; cardiac ablation on 06Mar2017; central venous catheterization on 01Dec2018; stent placement on 11May2021 (insertion of non-drug eluting coronary artery stent); knee operation/knee surgery on an unspecified date; pneumonia on an unspecified date; pulmonary embolism on an unspecified date; hepatectomy on an unspecified date; COVID-19 on an unspecified date; ex-tobacco user from 01Jan1076 to 31Dec2006 (Pks/days: 1.50, Yrs: 30.00, Pk yrs: 45:00, Yrs since quitting: 14.4); primary pulmonary arterial hypertension (Pulmonary arterial hypertension), arteriosclerotic heart disease, nonrheumatic aortic valve insufficiency, shortness of breath, and febrile illness from unspecified dates Concomitant medications included allopurinol (ZYLOPRIM Tablet 100 mg), amlodipine besilate (NORVASC Tablet 5 mg), doxazosin mesylate (CARDURAN Tablet 2 mg), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA), furosemide (LASIX Tablet 40 mg), hydralazine hydrochloride (APRESOLINE Tablet 100 mg), metformin hydrochloride (GLUCOPHAGE Tablet 1000 mg), pantoprazole sodium sesquihydrate (PROTONIX Tablet 40 mg), simvastatin (ZOCOR Tablet 10 mg), all from 23Mar2021 and ongoing; amlodipine besilate and acetaminophen tablet both from unspecified dates, salbutamol sulfate (VENTOLIN HFA) from 07Dec2020, acetylsalicylic acid (ASPIRIN Chewable tablet 81 mg) from 14May2019, fexofenadine hydrochloride (ALLEGRA Tablet 180 mg) from 09Feb2015, fluticasone propionate (FLONASE) from 24May2017, guaifenesin (MUCINEX Tablet 600 mg) from 05Nov2019, saccharomyces boulardii (FLORASTOR Capsule 250 mg) from 26Oct2020, all ongoing; salbutamol (PROVENTIL) from 30Mar2021; losartan potassium (COZAAR Tablet 100 mg) from 23Mar2021, glyceryl trinitrate (NITROGLYCERINE) and oxygen from unspecified dates. The patient previously took rivaroxaban (XARELTO) as anticoagulant therapy and experienced anaphylactic reaction (drug hypersensitivity); ibuprofen and experienced drug hypersensitivity (told not to take after stent put in May); morphine for pain and experienced drug hypersensitivity; ceftriaxone sodium (ROCEPHIN) for pruritus and experienced drug hypersensitivity and rash (tolerates penicillins). Historical vaccines included Pneumococcal vaccine polysacch 23v in 18Jan2007 at age 57 years old and on 30Apr2018 at age 68 years old for immunization; Influenza vaccine on 27Sep2011 at age 62 years old, on 10Jan2013 at age 63 years old, on 12Nov2013 at age 64 years old, 16Oct2014 at age 65 years old, 10Nov2015 at age 66 years old, 14Nov2016 at age 67 years old, 25Sep2017 at age 68 years old, 29Oct2018 at age 69 years old, 13Sep2019 at age 70 years old for immunization; Tdap on 17Oct2011 at age 62 years old and on 20Oct0218 at age 69 years old for immunization; Zoster on 30Jul2012 at age 63 years old for immunization; Pneumococcal vaccine 13v on 10Aug2015 ag age 66 years old for immunization; Quadrivalent Influenza vaccine on 08Sep2020 at age 71 years old for immunization. On 29Apr2021, the patient experienced fever, tachycardia, hypotension, acute on chronic hypoxic respiratory failure and acute exacerbation of chronic obstructive pulmonary disease. All events resulted to hospitalization (as reported). The patient was admitted for the evaluation of fever, tachycardia, and hypotension that started 24 to 48 hours after he had received first COVID-19 Pfizer vaccine on 26Apr2021. He received 1 liter of IV fluid bolus and Tylenol (paracetamol). The patient had had mild acute on chronic hypoxic respiratory failure and was placed on nasal cannula. He received solumedrol (methylprednisolone) 3 times doses. His computed tomography angiography (in 2021) revealed no evidence of pulmonary embolism or pneumonia. It was reported that the patient had an injection in his neck on 12Apr2021. On 01May2021 at 11:45, the blood pressure was 124/82 mmHg, pulse rate 71 beats/min, respiratory rate 18/min, temperature 36.7 degree Celsius, and SpO2 was 96 %. The patient improved progressively and remained hemodynamically stable. His blood culture was negative at 48 hours was discharged with a portable oxygen. On 24May2021, the patient had physician office visit for COPD, where it was reported that the patient received 2nd COVID-19 vaccine dose 7 days ago (17May2021) and felt very fatigued with some fevers for 3 days. The patient was doing better at the time of office visit. The review of system was positive for shortness of breath. The pulmonary physical examination revealed rales from right and left-lower fields. There was no Tachypnoea or respiratory distress. The cardiovascular physical examination revealed normal rate, regular rhythm, and normal pulses. The vitals examination revealed blood pressure 140/70 mmHg, pulse rate 87 beats/min, respiratory rate 16 /min, temperature 36.7 degree Celsius, and SpO2 was 95 %. The action taken in response to the events for treprostinil sodium was unknown. The patient recovered from fever on 20May2021 and was recovering from the remaining events. Case Comment/Senders Comment: The company has assessed the serious adverse event of acute respiratory failure, chronic obstructive pulmonary disease, tachycardia, hypotension and pyrexia as not related to IH treprostinil and TD-300/A device. Acute respiratory failure, chronic obstructive pulmonary disease were likely due to exacerbation of underlying PAH and COPD. Pyrexia, tachycardia, hypotension were possibly a reaction to Pfizer BioNTech COVID-19 vaccine. The reporter's assessment of the causal relationship of all events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on the lot/batch number has been requested.; Sender's Comments: There is no reasonable possibility that the events acute respiratory failure and COPD exacerbation were related to BNT162b2. These are more likely associated with the underlying PAH and COPD. Based on the temporal relationship, the association between the events fever, tachycardia, and hypotension with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Productive cough; Wheezing; This is a spontaneous report from a contactable physician, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021 at 13:00 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia, adult-onset asthma, aortic valve replacement, cataracts and penicillin allergy. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 27Feb2021 at 15:00 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 23:00, ten hours after second shot, the patient developed asthma symptoms including a very productive cough and wheezing, which lasted for four days. On second day, the patient was treated for the events with prednisone 40mg/d. Although, the patient had adult-onset asthma but had not received any episode like this in ten years. The symptoms were 90% improved (as reported). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of very productive cough and wheezing was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Patient presented 7/2 with SOB, fever, muscle aches, generalized weakness, and dry cough. Diagnosed with COVID-19. Reportedly started on ivermectin, dexamethasone, azithromycin, and an inhaled steroid by PCP with initial improvement, and then significant worsening warranting admission. Was admitted to ICU, and emergently intubated on 7/2. As of 7/6, patient remains intubated on mechanical ventilation in the ICU.

Extreme join pain, shortness of breath, water retention, sleeplessness, decrease urine output, urine odor, fatigue, weakness, lack of appetite (all came on suddenly about three weeks after 2nd dose of Pfizer COVID vaccine).

First dose of Pfizer COVID-19 vaccine on 3/22/2021, followed by the 2nd dose on 4/12/2021. 7/14/21: Patient arrived to ER with COVID symptoms after testing positive on 7/7/2021. Per ER records, the patient received the positive result on 7/10/21 and went to see his PCP who prescribed the patient a Zpack and cough medicine. The patient finished the Zpack but was still having body aches, shortness of breath, fever, loss of appetite, and fatigue. 7.15.21: in the ED patient found to have hyperglycemia, anion gap metabolic acidosis, worsening kidney function, and multifocal pneumonia. Diagnosed with acute hypoxic respiratory failure due to COVID-19 pneumonia, sepsis secondary to COVID pneumonia. started on remdesivir

This is spontaneous report received from a contactable consumer (patient wife). A 71-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on an unspecified date at age of 71 years old as single dose for Covid-19 immunization. Medial history included high blood pressure; heart attack in 2005 and had been fine; diabetic for years and just taking a pill for it, not that bad; covid-19 with bed sore, pneumonia due to covid. The patient had Covid back in February he was hospitalized for about little over 2 weeks and he was released, with he had double Pneumonia and that's why, he was in the hospital that long and he waited the 90 days because all the doctors said, he should get vaccinated for it. Concomitant medications included lisinopril for high blood pressure, glimepiride for diabetic, pioglitazone, prazosin, pravastatin, acetylsalicylic acid (BABY ASPIRIN), something for sugar and high blood pressure. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on May2021 for Covid-19 immunization, experienced swelling in the armpit area/swelling underneath his armpit and swelling underneath his armpit, his lymph nodes. After taking the first dose of the Covid vaccine he experienced swelling in the armpit area. With the second dose he felt dizzy, could not breath, weakness, pain in the armpit area/ arm, left side of the chest/breast area, loss of breath, like having a heart attacks, lightheaded, Dull pain in the chest which came and went. He had seen his doctors who have done some test, including CAT scan of the brain, no signs of mini stoke. He lost his memory for 2 hours; he did not know what was going on; he was answering wrong to the questions asked. His doctor told him that he will prescribe him something to calm the nerve ending like he was experiencing. After the covid virus he was feeling fine until he received the Pfizer covid vaccine. He stated his doctor told him that he read the vaccine was causing some of these problems in people. Pfizer should let the public knew about these issues. The reporter wanted to know if anyone had died due to loss of memory and chest pain after getting the Pfizer covid vaccine. He had a first one, it wasn't terrible the second vaccine he had it about two weeks ago now, he was experiencing real shortness of breath and that was 2 weeks ago and also he had a weird sensation where had a shooting pain come across his chest to his breast and he felt like he was out of breath and now he still like really-really out of breath, it took a long time to go away. The patient got the vaccine around it was 2 weeks ago. Today was the, Thursday 13. So, they roughly around the first or second you know, that's when the patient got the last shot and then he started to feel these pains around the 08Jul2021 and it just start to get worse then around the 10th, that was Saturday. The patient had 5 of them, that day and then Sunday 11Jul2021, he had about 4,5 and he was in the hospital when he was having them, he was in the emergency and then they what they done an MRI of his brain, they thought, he might be having a mini stroke and it wasn't it and the doctor said it could be the shot that got for breath and he went to his regular doctor today and she said the same thing she was going to heart doctor tomorrow but his regular doctor said she believed, it could be the shot. The patient got the second shot on left arm because he didn't wanna mess around the right arm again to get swelling back. It's on his left arm, that's where the pain started, right underneath right across from his breast okay, underneath his arm, it went, it started really the patient could feel prominent line and it's stronger and stronger and then it come close to his nipple of breast and then it started to go away and then he got like you know dizzy again and after little bit of dizziness went away and then but he was on weak side again. The patient had tones of blood work. Outcome of events: It's definitely persisting because he just spent the last weekend in the emergency room and he hadn't had these problems before. Reporter stated about treatment, "Well. He did, when he was in the hospital, he was hospitalized and they did an MRI of brain, they checked the his blood vessels in his neck and also they did a chest X-ray and they were saying because one Saturday, he lost his memory like for 4 hours he didn't know where he was, he knew who I was but he didn't know where he was why he was there, he totally didn't know what present, it was he didn't know, what year it was, like he lost everything for about you know about 4 hours I guess and about 5 O'Clock he knew everything, so they couldn't figure that out that's why, they did all these test they thought that he had like any mini stroke or something but they did rule that out." When asked if still in hospital, reporter stated, "No, he's home he was hospital yesterday. Today's what actually what was there Saturday and Sunday, and today is Monday he was released on Monday." Reporter again handed over the phone to the patient. The patient stated, "it was nothing you know and the scary part is like, my wife said you know, I lost my memory and I never had done that before either and the doctor, that ordered the MRI of my brain. He came to my room and he said to me, we can rule out that you didn't had a mini stroke, he says everything is fine. He says I really think it's the shot that you got or the one or two has caused it, he said that the Pfizer shot or the, you know, whatever he read where it does affect your nerve ending and he is saying it could have been a nerve ending or something coming from under my armpit over, but today I didn't have none of them attack but I am, my light headed and my breathing are hard, I mean, I can breathe, my lungs are okay, they took an X-ray my lungs and everything. Everything is Okay with my lungs but you know, my breathing like last night I was going to die in bed. I was breathing so, hard like I was afraid it's my breath and I came through the night but I felt the same way today and all day I felt, shortness of breath and like light headed but I didn't get any more attacks. I underneath but still like I feel like cow in other words." The patient had read, and specialist that read the MRI and both of them, they both think, It could be the shot that the patient got. Treatment was received for the events. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

difficult breathing,shortness of breath.; 2nd dose, night sweats, mid morning since 04/26/2021 to prevent. Today 4:00 am sweats; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 at 12:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included renal transplant, hypotension, glaucoma, rubber sensitivity (known allergies: Latex (Rash)). The patient's concomitant medications were not reported. The patient had dose 1 of bnt162b2 on 05Apr2021 at 12:00 AM (lot Number: EP7533, vaccine location: Left arm). The patient experienced 2nd dose, night sweats, mid morning since 26Apr2021 to prevent. today 4:00 am sweats on 26Apr2021, difficult breathing,shortness of breath on 27Apr2021 at 04:00. Outcome of both the events was unknown. No follow-up attempts are needed. No further information is expected.

The day following the vaccine, the patient complained of throat issues and anxiety. This was not new... however . That evening he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative. On 12/30/2020, patient complained of sternal pressure and was transferred to the hospital. The patient died 12/31/2020 and records obtained from the hospital indicated the patient died from a massive myocardial infarction.

Vaccination on Friday. Aches and stiff joints started early on Sunday. I hardly slept that night alternating from being too hot to too cold. Monday evening around 6pm: Chills started, sinus congestion, runny nose, general weakness, shortness of breath. I took a hot shower and later used a rescue inhaler and was able to get my breathing back to normal. I dressed in warm clothes and went to bed fully dressed around 10pm. 8am Tuesday I got up after a sound sleep and the symptoms were mostly gone except for a little sinus pressure and some joint soreness.

Received 1st COVID vaccine on 01/28/2021. Started to have some fevers, body ache, cough, mild sob starting 02/01/21. Tested COVID positive on 02/03/2021. Was been measuring SpO2 at home and was in the high 80s at home by 02 so referred to ED on 2/4/2021. Admitted 02/05/2021. Started on dexmethasone and supplemental oxygen.

chest pain Narrative: Patient received dose #1 of Pfizer COVID vaccine at vaccination site on 2/7/21 and subsequently presented same-day to Hospital with complaints of chest pain, mild shortness of breath , weakness and headache. He tested +COVID on admission that same day.

Acute on chronic congestive heart failure, unspecified heart failure type; Cough; ESRD (end stage renal disease); Hypertension, unspecified type; SOB (shortness of breath); Shortness of breath

Baseline: 72 yo male social worker retired with asthma, CAD, some memory loss doing well quarantining and masking. January 22: First dose Pfizer// January 30 repeated chills and malaise/February 1 wife called saying she was worried about vomiting, diarrhea, lack of intake//February 2 no vomiting, able to keep down clear liquids and bland food, canceled primary care appt//Febrary 3: Patient examined: Afebrile, BP 140100 not orthostatic, HR 80 T 98.6. Negative exam. Was oriented but wife mostly spoke for him. "I've never been this afraid in my life" February 6 exhausted, unable to do activities of daily living. Fluids being pushed and eating bland food ok/ February 12: Feels ok. Covid PCR rtn'd negative. February 13: Second dose of Pfizer//February 17 malaise returns, poor oral intake/February 19 early AM found walking on street about 1/2 mile from his house disoriented. When he was return home by person who turned out to be his psychiatrist thought he was in DC.

Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: FACE.THROAT NUMBNESS AND TINGLING-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

Mild affects began 1st night with cold sweats, wild dreams, waking up gasping for air. Very tired the next day, just felt lousy. 2nd night was same, not feeling great the next day either. Really hoping to feel better tomorrow, and get a normal nights rest tonight.

PATIENT REPORTED THIS ON 03/01/2021- WITHING 5 MINUTES OF IMMUNIZATION HE HAD PUFFED UP UPPER LIP , A LITTLE SWELLING IN THROAT AND LITTLE DIFFICULTY SWALLOWING. IT LASTED ABOUT 15 MINUTES AND THEN PASSED. Patient also stated that this reaction was similar to a reaction he had previously when he had a banana at age 21. now he is 72. Patient spoke to his Doctor on 03/01/2021. Doctor advised him to take Benadryl 25 at 8 am and 6 hours later after the second dose of covid-19. We advised him to get his second dose at a hospital or doctor's office if possible.

really tired; headache; started throwing up; diarrhea; dry hives; feeling kind of 'wheezy'; stomach was still upset; couldn't breathe, little short breath; Feeling lousy; I had a temperature; heavy sweat; This is a spontaneous report from a contactable consumer (patient). A 72-year-old-male patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL9261, via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. Medical history included Histoplasmosis (it's a lung fungus), Hepatitis B, and meningitis. Concomitant medications included unspecified blood thinner. The patient got the first Pfizer COVID shot Friday morning. He experienced feeling lousy. And about 2 o'clock in the afternoon on 29Jan2021, he started feeling kind of 'wheezy' as by 1 o'clock and his stomach (incomplete sentence). At 3 o'clock, he started throwing up, he had the dry hives for about 3 hours along with diarrhea. And then he had a temperature. He laid down and woke up just heavy sweat on the break down he meant big time. At 2 in the morning (30Jan2021) he couldn't breathe, little short breath and that lasted about 3 hours that was Friday night. On Saturday (30Jan2021), his stomach was still upset with diarrhea, still had the headache and really tired on Saturday and today Sunday. No treatment received for the events. He asked if he should take the second shot. The outcome of the events was not recovered.

At some point after the 2nd vaccine the patient had increased weakness and shortness of breath. He presented to the ER and was noted to have acute kidney injury. Patient was admitted from 2/23- 2/27.

About 5mins after injection, patient started having sob. Denies chest pain, throat swelling, tongue swelling, rash, itching or dizzy. SOB resolved within 10 mins. BP 120 Pulse 77 Ox 99%. After 30 mins observation, ox was 99%.

Pulmonary embolism; Multiple clots in his lungs; Shortness of breath; This is a spontaneous report from a contactable consumer (patient wife). A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown and expiration date not reported), via an unspecified route of administration on 10Feb2021 at a single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient previously took first dose of bnt162b2 (EL8982) on 19Jan2021. The reporter (wife) stated that she and her husband both took the Covid vaccine. The patient (husband) is the one who have the adverse reactions. On 19Jan2021, she and her husband had the first shot, the Pfizer Covid shot. On 10Feb2021, they had the second shot. Just today she picked her husband from the hospital, they dismissed him for today because on 18Feb2021, she had to take him to emergency room because he had pulmonary embolism. He has multiple clots in his lungs. This is nothing that they dealt before with him. The reporter is afraid that it might be related to have taken the vaccine. Reporter stated that when she took him to the emergency room, it was 18Feb2021. Now he had a little shortness of breath for few days before the 18th but they didn't realize that he was having a big problem. He fully developed this on 18Feb2021. The reason for hospitalization was pulmonary embolism and blood clots in his lungs. He is little bit slow like the reporter said she got him to the hospital where he stayed 3 days she guess with pulmonary embolism, from 18Feb2021 to 21Feb2021. He had lot a of lab work while he was in hospital on these days the wife described. He had blood work, Echocardiogram, CAT scan, Ultrasounds, Chest X-ray, Covid rapid test, they haven't got back the result yet. Outcome of the events was unknown.

Patient received Covid19(Pfizer) vaccine on 02/26/2021 at 3.55pm and on 02/27/2021 in the morning he had swelling in his left leg ( patient had knee replacement in same leg 9 months ago). He waited 2 days and still no improvement. He went to Beaumont urgent care on 03/03/2021 and he was referred to emergency room at hospital. He was admitted due to blood clot in left leg and lungs, where he had leg surgery. He was prescribed Eliquis 5 mg twice a day.

Diffuse myalgias and joint pains including pleuritic chest onset approximately 36 hours after dose administered. Resolved after another 24 hours. Recurred again for < 24 hours and then resolved.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Patient recieved vaccination from me at approximately 3:30 PM, 3/12/21. Patient was monitored for adverse reactions for 15 minutes and left without incident. At approximately 7:30 PM patient's wife called the pharmacy and reported that after dinner, her husband began vomiting, breathing shallowly, and became too dizzy to stand. I instructed the patient to immediately call 911 and told her that her husband should not recieve the second dose of vaccine. Currently, patient status is unknown.

About 27-28 hours after injection felt strong pain in left lung area. Got progressively worse, especially at night when lying in horizontal position. The pain became extreme, could hardly breathe (inhalation causing extreme pain) and couldn't really walk on morning of March 6 (about 66 hours after vaccination. Called General Practicioner and he said to go to Emergency Rm. A catscan showed a small blood clot in each lung. Given blood thinner injection. Subsequent Ultrasound of legs showed no clots there. Released 48 hours later, put on Eliquis -- 5mg -- two each time, twice a day for 6 days, then one each time twice a day. for 3 months.

On March 3, five days after the second Pfizer Covid shot, I developed Shingles. I am being treated for that, and it persists. In the past week, I have developed an extreme severe head cold, with congestion, heavy mucus, coughing/choking, and muscle aches. I have always been a very healthy person.

Second dose received on 3.13.2021. On 3.20.20. developed sleepiness and fatigue. Next day fever 103.1 and extreme weakness, fatigue, drowsiness and shortness of breath when going upstairs. Fever controlled with ibuprofen 800 mg. Next day (3.22.2021) same symptoms. Ibuprofen 800 mg again given . Taken to ER. Blood work and chest x ray normal. Next day fever 100.1 down with ibuprofen 400 mg. Continues with extreme sleepiness . Wakes up only when stimulated and given water. Had bad vivid nightmare, but seems oriented.

4-5 hours after vaccination he developed swelling in the back of his throat and a sensation of his throat closing. He had a change in character of his voice with hoarseness. He developed chest tightness and difficulty swallowing saliva. His uvula was edematous. He had severe throat discomfort. He was evaluated and hospitalized and required treatment for anaphylaxis with epinephrine, famotidine , IV methylprednisolone and diphenhydramine.

Patient is a 72 yr/o male with PMH significant for COPD, OSA (non-compliant with CPAP), DM2, HTN, HLD, CAD s/p CABG, AFIb (on Xarelto), and chronic diastolic CHF who presented to the ED by EMS due to respiratory failure. Per family- pt had been feeling unwell overnight and the checked on him several times and noted some "gurgling" respirations. EMS was called this morning as patient was found unresponsive. Upon EMS arrival they noted he was completely unresponsive with apneic respirations. He did have a palpable pulse. He was hypoxic to the 50s and cyanotic. He was nasally intubated without complication. During transport his mental status did improve. Patient unable to provide additional history at this time. On arrival to the ED, pt was placed on CPAP however TVs noted in the 200s and tachypneic therefore he was placed back on VC mode. Pt will be admitted to the ICU for further management

3/17/21 Pt presented to ED w/ a 4-5 day history of cough, SOB, chills, fever and poor appetite. Nasal swab + for SARS-CoV-2. CTA of chest showed pneumonia. He received on dose of Rocephin and azithromycin in ED. ATB discontinued upon admission to the hospital. Because of risk factors, patient was treated with bamlanivimab infusion. He was discharged to home on 3/19. At no time did he require oxygen.

Death; Heart attack; Shortness of breath; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 72 years, at single dose on 23Mar2021 at 10:00 (Lot number was not reported) for COVID-19 immunisation. Medical history included asthma, penicillin allergy and she was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient experienced death, shortness of breath and heart attack on 23Mar2021 at 20:30. And it was reported that the adverse event result in "Emergency room/department or urgent care" and patient was treatment with CPR. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not been tested for COVID-19 since the vaccination. Event outcome of events shortness of breath and heart attack was not recovered. The patient died on 23Mar2021 at 20:30. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death

Pt received first dose of pfizer vaccine lot number EL9262 on 02/23/21. Pt began developing SOB and feeling tired. Second dose of vaccination 03/18/21 Lot EN6208. Pt went to ER on 3/17/21- negative CXR. Sent home on steroids. No cardiac history. Returned to hospital 4/2/21 with worsening SOB- ECHO revealed estimated EF of 25% with diffuse hypokinesis. Pt c/o weight loss and fatigue. CT chest negative for PE. Was found to have small pericardial effusion with a large left pleural effusion. Started on Lifevest, entresto, furosemide and potassium.

In march I started becoming SOB and it continued to progress. It became so bad that I could only walk about 5-10 feed before becoming totally exhausted, needing to sit down for a few minutes. My heart rate remained sinus-tach running up to 120's. On March 4, 2021 I had an appointment with Dr. He sent me to the Hospital to have a CTA. The test was positive for a MASSIVE bilateral PE. Doppler studies of my lower extremities showed a partially occluded Palpitate vein in my right leg. I was admitted to the hospital and started on Heparin IV. I was also taken to the Cath- lab where I underwent a Thrombectomy of my right lung. The Cath-lab quit working so the procedure was stoped and the left lung was not treated. On admission to the hospital my O2 sat was 97%. After the thrombectomy my O2 sat went to 83%. I was placed on Hiigh-flow O2 via nasal cannual. On March 8th I was started on Lovenox SQ for 30 day and discharged from the hospital on March 9th. I am now on Eliquis 5 mg bid and doing much better.

2+ weeks after 1st dose = Extreme hot flash and then difficulty breathing..... 22 days after 2nd dose = Extreme hot flash and could not get breath - continuing SEVERE difficulty breathing.

Presented to the ER with dyspnea. Brought by ambulance from where he lives. Please note-this chart is entered after a review of all patients presenting to the hospital with diagnosis of DVT, PE or stroke since we started vaccinating for Covid-19 on 12/23/2020. He got a pfizer vaccine on 1/30/2021. We pulled all charts of theses diagnosis if it occurred within 14 days of vaccination.

This 72 year old white male hospice patient received the Covid shot on 2/20/21 and went to the ED on 3/27/21 and was admitted on 3/27/21 with shortness of breath, pneumonia, hyponatremia, anemia, bilateral pleural effusion, metastatic cancer and died on 4/17/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Sudden onset of pneumonia and Afib; Sudden onset of pneumonia and Afib; fever; chills; cough; chest pain on breathing; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) via an unspecified route of administration, administered into the left arm on 12Feb2021 (at the age of 72-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included rosuvastatin (ROSUVASTATIN) and timolol (TIMOLOL). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246) administered into the left arm on 22Jan2021 08:00 (at the age of 72-years-old) for COVID-19 immunisation. On 29Mar2021 01:00, patient had sudden onset of pneumonia and afib (atrial fibrillation), fever, chills, cough and chest pain on breathing. The patient was brought to the emergency room and was then hospitalized for 4 days due to the events reported. It was also reported that the patient was treated with antibiotics and heart medications. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 29Mar2021 and negative on 02Apr2021. Outcome of events was unknown. Follow up attempts needed. Further information is expected.

Several hours after 2nd vaccine shot my lungs began to ache. Not adverse pain, or breathing problems-- just s subtle ache. This continue for 3 - 4 days. No interruption of daily activities-- just that quiet ache. Heavier breathing upon exertion, but not interrupting routine. Though the aching is over, my breathing never fully recovered. I'm not a medical professional-- but estimating I lost 15% ish of my breathing/capacity. This doesn't interfere with daily activities, but is "present" with me all the time. Even walking the dog requires a brief slow down.

Death 1 week after 2nd dose of Phizer COVID vaccine, this person developed shortness of breath and was found passed away by his roomate.

Blood clot in right lung; Sore left arm at injection site; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscular, administered in the left upper arm on 03Feb2021 at 09:00 (batch/lot number: EL3248) as a single dose for COVID-19 immunisation (prevention). Medical history included rheumatoid arthritis from Dec2009 to an unknown date (takes daily pills for rheumatoid arthritis), squamous cell lung cancer early stage from Aug2018 to an unknown date, lung surgery to remove small portion of that and went on chemo in Aug2018, skin cancers prior to getting the vaccine, reading glasses (he needed prior to getting vaccine), blood pressure (abnormal) (takes blood pressure medication; takes daily pills). Family medical history was reported as none. Concomitant medications included nivolumab (OPDIVO) taken for squamous cell lung cancer early stage from 17Jan2019 to an unspecified stop date (getting it every 4 weeks for 2 years and 3 months; the bag was 480 ml); and unspecified blood pressure medication and rheumatoid arthritis medication. The patient experienced blood clot in right lung on 25Feb2021, sore left arm at injection site on 03Feb2021 and shortness of breath on Feb2021. The patient had the first Pfizer COVID vaccine on 03Feb2021 and second one on 01Mar2021. He did not really have any special events but then he had a CT scan on 23Feb2021, which was about 20 days after first shot. When he went in for doctor's meeting a couple of days later, they said he had a blood clot in right lung. He later stated he was not positive it was in the right lung. He told his doctor that he just got the shot, but they said they had not heard of any reports from Pfizer of people getting blood clots in their lungs after getting it. He thought about reporting then, but did not. He has no evidence that the blood clot in his lung was related to the vaccine. He was also a lung cancer patient and was on an immune therapy drug nivolumab from (name). He has been on it for over 2 years and started Jan2019. He was diagnosed with cancer back in Aug2018. It was squamous cell lung cancer early stage. He had lung surgery to remove small portion of that in Aug2018 and went on chemo. On 17Jan2019, he started on nivolumab immune therapy drug. Fortunately, it worked extremely well. He immediately started recovering and was feeling better. The last few CT scans indicated he had no sign of disease. It does not mean he was cured, but was healthy otherwise. The nivolumab spurred his immune system to eat the cancer cells. It stimulates your immune system. It has been a pretty successful drug and has been on the market for about 5-6 years. He and his wife both got shot on same date. The word on the street was that you should ask for Pfizer because it seems to have less side effects that people can get for vaccines. Pfizer's reputation has been known for having less common serious side effects. He had a sore arm and it went away about a day later. They prescribed rivaroxaban (XARELTO), a blood thinner, for his blood clot which he went on and got on a day or two later. He was hoping it was gone. He feels better. At the time, he did not know he had the blood clot. He visits his doctor for treatment for nivolumab every 4 weeks and every 4 months, they do a CT scan. At his last visit, he reported that he was still fine but lately experienced some shortness of breath. It was occasional and it comes and goes and was not all the time. He plays golf and noticed the shortness of breath during his game. He quit a couple of holes early and did not want to take any chances. The doctor later told him that a blood clot in your lung can contribute to shortness of breath. When he started rivaroxaban it was 2 pills a day for about 2-3 weeks and it was a starter dose. It was a little more in the beginning. He thinks it was 10 mg twice daily and then it went to 1 tablet a day for the last week at dinner and now it was 15 mg once daily. The two combined were greater to jump start you. It was not a special dose. He then corrected dose to 15 mg rivaroxaban twice daily for the starter dose for 2-3 weeks and one tablet daily for the last week of the starter. Then he switched to maintenance dose of 20 mg daily. He did not have a lot or expiration for the previous dose of 15 mg. The lot and expiration for the 20 mg was unknown because he believes the label was covering it. He stated he needed to get his glasses to read bottle. They were reading glasses and he needed prior to getting vaccine. Nothing has changed with his vision. He was hoping to get off of them and has never been on them. He hopes it was not a long term thing. Second dose was given 01Mar2021, Pfizer COVID vaccine, BNT162B2, expiration was unknown. Injected in left upper arm in the muscle (intramuscularly). Second dose administered at 09:20-09:30. He takes blood pressure medication and did not see it was relevant. Takes daily pills for that and rheumatoid arthritis. In the past, he had a few skin cancers. All were prior to getting the vaccine. They were some squamous and basal cell. He has had nothing in quite a while. Nivolumab was helping skin issues. Squamous cell skin cancer was the same family as lung cancer. He did not have a lot or expiration for the nivolumab. He received it by IV infusion. Shortness of breath was mid Feb2021, on and off for a couple of weeks prior to doctor visit on 25Feb2021. He usually does not have much to report and mentioned it. It did not prevent him from doing anything and was not debilitating. One of his fellow golfers said he was huffing and puffing and he just poo pooed it away. He had a flu vaccine in Oct2021 (as reported). No further details provided. Blood clots in right lung morning time, unknown time. Sore left arm at injection site noon - to late in the day of the shot. Shortness of breath - sometimes he feels it in the morning or midday if active. He cannot say a straight time. No emergency room (ER) or physician's office visit required. Vaccination facility type was clinic. Not a military facility. On 25Feb2021, normally scheduled office visit and did the CT scan on 23Feb2021. He went in separate for that. He had the treatment on Thursday. He has another CT scan scheduled in third week of May2021. They were doing it early because of the blood clot. Hopefully, it was gone by then. Prior vaccinations (within 4 weeks): 1st and 2nd Pfizer COVID vaccine as mentioned above. CT scan on 23Feb2021, positive for small blood clot in single vessel in what he thinks was his right lung. All of his previous trouble with the lung cancer was in his right lung. He has never heard of anyone else having blood clots related to the Pfizer COVID vaccine. He does not think he has heard of any and wanted to know if there were any. He knows there was something in the press about the (name) vaccine with blood clots. When you do 120 million and have a handful of people, you may have a few things. He did not have any information on the people for (name) to report on. He knows of others who have had the vaccine and no one had any symptoms. No further details provided. The outcome was recovered on 04Feb2021 for the event "sore left arm at injection site"; recovering for the event "shortness of breath"; and unknown for the event "blood clot in right lung".

Beginning the day after the inoculation, my husband began feeling worse in terms of his difficulty in breathing. He used the Albuterol inhaler more than usual. It progressively got worse over the next 2 weeks, ending with my husband?s sudden collapse and death exactly 2 weeks later on April 5, 2021. The inoculation may or may not have been directly linked to his unexpected death, but I feel it may have exasperated his condition, which led to his death. And I feel it is important to report this to you. I later heard that he should not have been using his Albuterol inhaler one week prior to receiving the Pfizer vaccine. I don?t know if that is true, but that information was never told to my husband, if it is.

Fatigue, shortness of breath, worsening orthopnea, leg swelling, chills, nausea, runny nose, productive cough, loss of taste

Difficulty breathing,leg weakness, can't walk more than 30 feet without getting winded, needing to sit down.

Flu symptoms of body aches, nausea and retro-orbital headaches. Within 2 days after the onset of those symptoms, significant increase in hypertension with systolic readings of 150 to 175mmHg and diastolic readings 105 to 115 mmHg. at 5 days mild asthma symptoms that required oral steroid and topical inhalers for 7 days. Flu like symptoms took 6 weeks to resolve and BP required change in medication and 3 agents at moderate dosage. Those effects haven't abated.

almost felt like shingles; difficulty breathing; lesser sense of taste; itchy; burning; rash; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date was unknown), via an unspecified route of administration, administered in the left arm on 04Feb2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history included hospitalized for pneumonia in Sep2020 and treated with "mega-doses" of prednisone, antibiotics (unspecified) and oxygen wherein he recovered, came off oxygen for 1.5 months, but then after Christmas 2020, went back on the oxygen, from 07Jan2021 through 12Jan2021 the patient was hospitalized again and CT scans and cultures were performed on his lungs which returned a diagnosis of MAC complex. The patient is awaiting treatment for this after lung cultures mature. The patient also has chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing diagnosed 20 years ago, congestive heart failure (CHF), stomach issues, rash also on a portion of his face and eye sensitivity all from an unknown date and unknown if ongoing. The patient also had a heart attack and a triple bypass in May2020 and ongoing diverticulitis that has been going on forever since an unknown date. The patient is taking "a lot of other meds" (unspecified) for heart, lungs and digestive things. The patient previously got a regular flu shot (unspecified) and got feverish, chills, achy and his arm hurts. After the patient received the first dose of the vaccine on 04Feb2021, that day and night he had no symptoms. On 05Feb2021, the patient developed an itchy, burning, rash everywhere but legs and feet that "almost felt like shingles", which escalated over 5 days, tapered off a little on Wednesday, Thursday it was receding, by Friday 12Feb2021 it was basically gone. The patient went to a dermatologist office and they did not know about the rash. He called his pulmonologist and they told him not to get the second dose due to his underlying conditions. He was in the hospital back in Jan2021 and they found something on his lung and he is now working with infectious disease people, they told him to see an allergist, he cancelled his appointment for the second dose. The patient wants to know if this rash is being reported and was hoping that maybe someone would have seen or heard of something like this. The patient also reported that he has a lessened sense of taste that started on an unspecified date, around Tuesday, and he has had some difficulty breathing during all of this as well, unsure if it is related to the vaccine or his underlying condition. The outcome of difficulty breathing and lesser sense of taste was not recovered. The outcome of the event almost felt like shingles was unknown while the outcome of the other events was recovering. Information on the lot/batch number has been requested.

His body was beginning to shake; his whole body was aching, his back, everywhere, from his legs to his toes. It was maybe in his muscles; Shortness of breath; Headache; Little fever; Whole body from his neck, back, toes, and arms went to aching all the way down; Nervous; Tired feeling; could not sleep from the pain; This is a spontaneous report from a contactable consumer. This is a 72-years-old male consumer (patient) reported that he received 1st dose of BNT162B2 (COVID-19 VACCINE; lot EW0164; expiry date 31Aug2021) on 17Apr2021 0920 for COVID-19 Immunization. He took an arm out of his sleeve and they asked him which arm. He said his right arm and they gave it in the muscle section. They did a couple taps and said he might feel a little pinch. Medical history included COVID-19 from 30Dec2020 (tested positive on 30Dec2020, It shuts the whole body down. He could not even get his bowels to move. His doctor said it was because Covid affects the whole body system.) and Covid pneumonia (it attacked his lungs. He was in the hospital for 2 days. He came out of it and the CDC guidelines said to wait 90 days before he got his first shot of the Covid vaccine), blood pressure, cyst, stomach problem, allergic to penicillin (He had a penicillin shot years ago and he broke out all over. His mom said not to take it. He had rashes all over his body.), glaucoma. Family history included diabetic. Before his mom and dad passed they were healthy. His dad was 92 and his mom was 90. Everything was good. His mom was diabetic, and his dad was perfectly healthy. Other medical condition included with his lungs he has something they call psychodosis or something like that. He is going through a lot of problems with his stomach. They did tests and X-rays and different things to see what was going on inside his stomach and chest. It has been years, he has had the lung problems for awhile. He has shortness of breath and something with his thyroid or lymph nodes. That has been for a while. He had X-rays and a CT back in January when he was in the hospital. Those were on the 12th and were of his chest. They took the X-rays on the 13th. He had 2 to 3 chest x-rays and one CT. The last chest X-ray he had was in February to see how the pneumonia was doing. His doctor said it was looking better and to just move slower and take things easy. Past drugs included blood pressure pills (propazol or something like that). All of this started with whatever happened to his body after he had Covid-lung problems and everything. He was told to keep taking whatever medications he was on. He was not on any antibiotics or anything. They gave him antibiotics for a cyst he had, but he did not take those. They were too strong, and he stopped those about 2 to 3 weeks before he had the shot. He only took 3. The patient had tried feeling, headache, little fever, nervous, shortness of breath, Whole body from neck, back, toes, and arms went to aching all the way down on 17Apr2021. The shortness of breath started between 1300 and 1330. The pain was before everything else starting between 1600 and 1700. The headaches and stuff got him up at 0200 to 0300 and then he could not sleep from the pain. Everything else comes and goes but the pain was the longest. He sat for close to 40 minutes after the shot because he did not want to leave early. He was tired because he had to do the Covid test walk. He had the Covid test which was negative. Then he had to do a walk at about 1330 to determine if he should still be on oxygen. He had been on oxygen for about 2 to 3 months as he previously had Covid pneumonia. He had dropped his level to 91 when they put him in the hospital. Everything was better now. It was a little better once he came back home. It was because he had to do a 6 minute walk. He had a tired feeling because 6 minutes after the shot they had to determine if he still needed oxygen or not. He told the tech he just had the shot and asked if he should do the test. They said he had to do it. They sat him down and were checking his heart rate and oxygen level. He also had a headache and a little fever. Later that afternoon he came home at about 1600 to 1700. He was okay all that day and ate a little and got ready for bed. Once he laid in bed his whole body from his neck, back, toes, and arms went to aching all the way down. He thought it had to be this shot. He took Tylenol and tried to lay down. 0300 that morning he thought he might have to go to emergency. The paper said those are some of the side effects that he would probably experience. He got up and got nervous like he was getting ready to shake a bit and started walking. The pain was still there in his body. He tried to be calm and not panic. He took another Tylenol. He could not lay flat. He had to push his bed up to the wall and put a pillow on his back and the back of his neck to sleep straight up. Sunday morning things got a little better and he went out. He came back in at about 1200. Between 1400 to 1500 his symptoms came back. He thought he should go to emergency, but he did not go and waited. He took another Tylenol. It was between 1500 and 1600 that it all cleared up. It had to be from the shot. He did not get any pain when they gave him the shot, he had no pain in his arm. Then something broke loose and his whole body was aching, his back, everywhere, from his legs to his toes. It was maybe in his muscles. He talked to a lot of people and his neighbors who had it and they felt nothing. Another lady said after she had it she only had one hour of sleep and could not sleep from it either. The same thing happened to him. The headache did not last long. He took Tylenol for it. The only thing that lasted long was the body aches. He held off going to the emergency and it cleared up. He was going to go to the emergency Monday morning. The aches were gone now. The only pain now was one that he had all the time before that. This was altogether different because his body ached all the way down his back, arms, hands, legs, feet, toes, everything. The fever went away the same day. Only the pain lasted long. Even the nervousness went away. His body was beginning to shake. All of this was probably created from the vaccine. They said if he experienced pain to take Tylenol. He was taking these before he had the shot. All he can see on the bottle is 30047112. His kids brought this to him back in February of this year when he had Covid. Lot: SLA065, expiration date: Aug2024. They are 500mg, 100 count. The seals were not broken or anything, he always checks that out before he takes it. He checks everything out to see if anything is damaged. Outcome of the events tired, headache, fever, nervous was recovered on 17Apr2021, event whole body aching was recovered on 18Apr2021. No follow-up attempts are needed. No further information is expected.

Wife reports that patient started declining on 4/5/21 after his second covid immunization. He started to have intermittent intermittent fevers, shortness of breath and labored breathing. Wife reported he would "get sweaty and hot " and therefore she would give him tylenol. He saw his pcp 2 days later on 4/7/21 for these symptoms. In addition she noticed him to present with decline in his cognition and hemibody weakness and swelling. His pcp was also concerned about diastolic dysfunction. He received an outpatient ECHO. He was placed on lasix and referred to cardiology. On 4/19 He saw cardiology who ordered EKG and reviewed his echo. Felt that his afib was likely contributing to his shortness of breath. His echo and recent blood work revealed preserved EF. He had occasional scattered wheezes on exam and therefore inhaler and cxr was ordered. On 4/22 he presented to the Emergency room for breakthrough seizure. Breakthrough seizure lasted longer than usual (20 minutes), so ED performed a CT head, which showed an age indeterminant lacunar infarct in the anterior limb of the internal capsule. ( new from MRI 2 months earlierI) .

flu-like symptoms; oxygen saturation is low; having difficulty breathing; experiencing a rapid heart rate/ had tachycardia, fast heart beat; being tested for Covid 19; complaining of feeling unwell since receiving the first dose of the Pfizer Covid vaccine; his nose was very stuffy; needed to blow his nose like 100 times; This is a spontaneous report from a contactable consumer (patient's daughter). A 72-years-old male patient (reporter's father) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date was not reported), via an unspecified route of administration, administered in arm on 01May2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, tachycardia. The patient's concomitant medications were not reported. On 02May2021, the patient was complaining of feeling unwell since receiving the first dose of the Covid vaccine. Caller states father has been having flu-like symptoms. His oxygen saturation was low and he was having difficulty breathing. He was experiencing a rapid heart rate and currently was being tested for Covid 19, he was having chest ray done, and blood work. his heart rate was like 140 and then his oxygen would go down to 80. Caller states she didn't know if Pfizer has ever heard of symptoms like that. Caller states she just wanted to know what was going on, he's in the hospital now. The patient had tachycardia, fast heart beat. Caller states he is 72 years old, he was just laying down and felt his heart really bad, they used a monitor and his heart rate was 140, it was super elevated. Caller states they used the oxygen thing that they put on his finger and the oxygen levels were 80 so it was really low. Caller states he was completely fine, he never went out of the house, he was completely fine, normal. Caller states he does have hypertension though and he drinks medicine for that but she doesn't know which medicine it is. Caller states the first day they applied the vaccine, he felt good. Caller states the second day, he didn't feel good, had flu-like symptoms, his nose was very stuffy, he needed to blow his nose almost 100 times, he was not feeling well at all. Caller states her mom had to take him to the hospital. Reporter enquired if my father could take the second dose since he had this reaction and got answer that should not get COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of this vaccine and had a severe allergic reaction to any ingredient of this vaccine. The patient was taking Pfizer Covid vaccine because he wants to be protected. Caller verifies the patient is continuing to have all symptoms reported still. Caller states he was super healthy and he just went there and took the vaccine and he never goes out, so she doesn't know. Caller reports all of patient's symptoms reported have worsened. Caller verifies it was an injection in his arm, but doesn't know which arm. Caller also unsure of dosage given. Caller states they were like no only Pfizer, so he waited so long for Pfizer and finally when he applied to Pfizer and got it, he was so happy and so now he's so sad because he feels bad. Caller requesting to be transferred to the medical staff at this time. Caller states she doesn't have time to finish the report for her father or herself because her lunch break is almost over. The patient underwent lab tests and procedures on 02May2021 which included heart rate: 140- super elevated , oxygen saturation: 80 -really low , covid-19 positive: positive .The seriousness of the event was considered as serious hospitalisation by reporter. Outcome of the events was not recovered. Follow up attempts are needed. information about lot/batch number cannot be obtained.

Office Visit 3/15/2021 with, PA-C COVID-19 Dx Follow-up Reason for Visit Progress Notes , PA-C Encounter Date: 3/15/2021 Cosigned by: DO at 3/20/2021 6:25 PM Expand AllCollapse All Assessment/Plan Problem List Items Addressed This Visit None Visit Diagnoses COVID-19 - Primary Unfortunately, patient does not meet criteria for monoclonal antibody infusion therapy as he is 10 days from start of symptoms. At this time I have sent in a prescription for Tessalon Perles and a ProAir inhaler for him to use with increased cough or shortness of breath. You tested positive for COVID-19 today. Discussed recommendation for self-isolation from others at home. You should try to stay in the specific sick room and use a separate bathroom if possible, even if you are feeling better. You can be around others 10 days after your symptoms first appeared, and you have had 24 hours without fever without the use of fever reducing medications, and other symptoms of COVID-19 are improving. If you do come into contact with others at home, you should stay six feet away and wear a mask. Please follow good handwashing hygiene: wash your hands with warm water and soap for 20 seconds, or when hand washing is not available, use an alcohol based hand sanitizer that is at least 60% alcohol. Please stay well hydrated and rest. May use tylenol for fever, chills, or pain. You may also use hot tea with lemon and honey to soothe your cough and salt water gargles for any sore throat. If you develop difficulty breathing, persistent pain or pressure in your chest, have any confusion, difficulty staying awake, please call us or go to the ED. Relevant Medications albuterol HFA (PROAIR HFA) 90 mcg/actuation inhaler benzonatate (TESSALON) 200 mg capsule Other Relevant Orders POCT COVID-19 Antigen (Completed) Pulse oximetry (Completed) SUBJECTIVE PT 72 y.o. male who presents for a sick visit with concern for possible COVID 19. Reports onset of symptoms started 10 days ago. Information was obtained from PATIENT. Reports some dry cough, mild shortness of breath, occasional headache, increased fatigue, loss of taste and smell, decreased appetite, congestion, rhinorrhea. Reports loose stool. Denies wheezing, fever, chills, myalgias, sore throat, ear pain, n/v. He was exposed to an individual who was exposed to someone with COVID. He had his flu shot and his first dose of the COVID-19 vaccination. Review of Systems Constitutional: Positive for fatigue. Negative for chills and fever. HENT: Positive for congestion and rhinorrhea. Negative for ear pain and sore throat. Respiratory: Positive for cough and shortness of breath. Negative for wheezing. Gastrointestinal: Positive for diarrhea. Negative for nausea and vomiting. Neurological: Positive for headaches.

unresponsive; had a stroke in his temporal, frontal and parietal regions of his brain and he has even had prior strokes too; feverish; they all fell down, her brother, her and the rollator; rapid heartbeat/ his normal heartrate is in the 60s and it was going from 110 to 140s and it wasn't coming down; had some blood clots that were thrown into the frontal, temporal and parietal region in his brain; agonal breathing; stopped breathing but then he came back so that's when he was intubated; felt very bad/ malaise/ feeling ill; vomiting in the trash can/ had stuff that looked like had came out of his mouth and he had vomit on legs; he just said that he hurt; nauseated; fatigue; his head hurt; having no appetite/ he ate one bowl of soup that the caller had made for him but he wasn't really eating; This is a spontaneous report from a contactable consumer (patient's sister) via a Pfizer-sponsored program. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 16Apr2021 10:00 (batch/lot number: unknown) as 2nd dose, single for COVID-19 immunisation. Medical history included blood clot years ago, ongoing leukemia (in remission), coma, gout (he takes a gout medicine), neuropathic pain, pain, high blood pressure, thyroid (disorder), varicose veins and uses rollator (his wheelchair with a seat). Concomitant medications included metoprolol taken for high blood pressure from an unspecified start date and ongoing; levothyroxine sodium (THYROXINE) taken for thyroid from an unspecified start date and ongoing; hydrocodone taken for pain from an unspecified start date and ongoing; imatinib taken for leukemia in remission from an unspecified start date and ongoing; gabapentin taken for neuropathic pain from an unspecified start date and ongoing; iron taken for an unspecified indication, start and stop date were not reported; folic acid (FOLATE) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; and ongoing unspecified gout medicine. The patient previously took morphine; he had a shot of morphine in the emergency room sometime before his COVID vaccine. Historical vaccine included BNT162B2 on 25Mar2021 (batch/lot number: unknown) as 1st dose, single for COVID-19 immunisation. Vaccination facility was PRIVACY she thinks. Prior vaccination (4 weeks prior) were none. The patient's sister reported that they both had their second dose and she forgot to tell the other woman she spoke to about herself because the caller's focus was on her elderly brother who was 72-years-old. They both received their COVID vaccines in the morning of 16Apr2021, a Friday, and within hours her brother felt very bad. She went downstairs and saw her brother vomiting in the trash can and he just said that he hurt and that he felt nauseated. This continued for a few days, in fact it continued for 4 days. He was beginning to feel better on Monday, but he was still not up to par. Then Tuesday she guesses her brother was feeling better. On Wednesday night she went downstairs and heard him around 2300 to midnight talking to the dogs and then the next morning she found him unresponsive (22Apr2021). Her first thought was that maybe her brother had a stroke so she called 911. In the emergency room he had a CAT (computerized tomography) scan and at first they said that he didn't have a stroke. But something very unusual was that her brother had a rapid heartbeat and his normal was around 60 but in the emergency room his heartrate was upwards to 120 to 130 to 140. He was then transferred to another hospital where they said the next evening that in fact he did have a stroke even though that first doctor said that he didn't have a stroke. The doctor didn't find any further information until 2 days later when the doctor thought her brother already had some blood clots that were thrown into the frontal, temporal and parietal region in his brain. She was a biologist so she can't say that the COVID vaccine caused this but she thought that Pfizer should be aware of his situation and then she was so focused on her brother that she forgot to tell the other woman the really bizarre things. She had asked certain questions to the doctor based on what her sister was telling her to ask. The caller asked the doctor if her brother was going to be seen by a neurologist and the doctor gave a rambling evasive answer and then turned on his heels and walked out and kicked her out of the hospital. They both had their COVID vaccines in the morning around 1000 or so and she doesn't know if he was vomiting still the next day or not but her brother felt really bad. He has chronic conditions and he generally just felt bad and he had thought that something was wrong with him. He felt malaise, fatigue, his head hurt and he was nauseated. He ate one bowl of soup that the caller had made for him but he wasn't really eating. That lasted for about 4 days and then he started to feel better on Tuesday, confirmed to 20Apr2021, and then he felt even better on Wednesday, confirmed to 21Apr2021, because the caller did take him on some trips. He doesn't drive. Her brother said that he felt feverish and the caller says that he felt feverish to the touch as well but the thermometer said that he didn't have a fever because it had an error sign when she took his temperature. Unresponsive: Her brother was fine Wednesday night around 2300, maybe midnight, she had heard him downstairs talking to the dogs and she knew that he was okay. Then the next morning, 22Apr2021, she found him slumped into his rollator (his wheelchair with a seat) and he was slumped over and had stuff that looked like had came out of his mouth and he had vomit on legs. He was unresponsive so she called 911 and said that she thought her brother had a stroke. The operator said to lay him flat and the caller was finally able to get him up and then his arm got hung up and the operator said again to get her brother on the floor and get him flat. She understands that this was important and she was able to do it but they all fell down, her brother, her and the rollator. Shortly after this the ambulance had shown up. The ambulance took her brother to the emergency room in town and they said that her brother's heartrate was fast. She gave them all of the relevant information but she didn't think to tell them about the COVID vaccine. They said that her brother's heart was acting eradicate and it was very fast. Again, his normal heartrate is in the 60s and it was going from 110 to 140s and it wasn't coming down. She told them that when he was unresponsive that she thought he was having agonal breathing. In the emergency room, her brother's breathing was still not very good and she heard the doctor say that her brother had stopped breathing but then he came back so that's when he was intubated in the emergency room. They did a CAT scan of his head and his neck and the doctor comes back and said that her brother didn't have a stroke. But that was not the case according to a different doctor's later assessment. Approximately around 1430 to 1445 on that Thursday, 22Apr2021, they transferred him to PRIVACY, where he was in the ICU (Intensive Care Unit). His heartrate conditioned to being very fast. He went from the emergency room to the ICU. Thursday when he got transferred to the ICU they didn't do any diagnostic tests that day, he was still intubated and his heartrate was still up into the next day, Friday, 23Apr2021. It wasn't until late in the afternoon that a doctor came in and said that her brother did have a stroke he has even had prior strokes too. They had done an MRI (Magnetic resonance imaging) on Friday of his brain, which was not what they did in the first emergency room, that showed that he had a stroke in his temporal, frontal and parietal regions of his brain. At first caller states that on Saturday, he opened his eyes but he was still unresponsive essentially but then she says that this statement was wrong because he actually didn't respond that quickly. He has gone into a coma once before and when he had came out of it a very unpleasant thing happened that was very personal so she was not going to tell it. On Saturday and Sunday the doctor didn't want to answer the callers questions, this was a different doctor than the first ICU doctor and this one didn't have good bedside manner. Finally on Monday, 26Apr2021, her brother started responding. He was moving his legs with purpose, he had tried to kick the nurse, and he had made some words. The day before this, on Sunday the caller had brought the priest in to bless her brother and he sort of nodded and he seemed to make movements but he was still not able to talk. Monday he said what sounded like words and then Tuesday he made, what seemed to her like, meaningful statements. She was told that he had an ultrasound of his neck to see if he had any clogged arteries or veins and the nurse said that the test results came back good that their were no clogs. But this was where the whole story just becomes awful. Caller discusses how there were issues with a cousin having power of attorney from 2015 that was supposedly no longer valid according to the caller and she had spoke with administration and then she got kicked out of the hospital on Tuesday because of a question she had asked the doctor about her brother seeing a neurologist. The doctor said that the neurologist makes his own schedule and it might be 10 days or more if he even decided he wanted to see her brother. When the doctor asked the caller how would she like her brother's care to be she mentioned that he was in a coma before and was being treated for similar circumstances from PRIVACY and that he was seen by a neurologist and she said that maybe her brother should be seen by PRIVACY and the doctor walked out and within minutes she was being escorted out of the hospital for belittling the doctor and calling administration. Now they won't even let flowers be delivered to her brother. Unfortunately the person who has been involved with him the most, the caller, was now barred from him. She was not saying that this was all due to the Pfizer COVID vaccine but why were they saying that she has a blood clot too. She has had headaches but they may be due to stress. She didn't feel sick like her brother. She has a question and she was really scared about the answer. She was just now reading that if you're on immunosuppressant drugs then you're not supposed to have the COVID vaccine. She asked was that true. Well her brother was in remission for leukemia and he was on a cancer medication called imatinib. Caller declined to speak to medical information about this and says it was already too late because he was already taking it and she doesn't know why he didn't stop them. Her brother's friends have tried to call and they were all getting the same statement, which she believes the hospital was stone walling, but the hospital says that they don't have a patient by his name and they have even told the florist the same thing. So caller was unsure if her brother has been discharged or not. He didn't seem to be in the shape to be shipped to a care facility but she doesn't know. It was hard for her to piece it all together. The hospital wasn't feeding her brother enough before she left so for all she knows they could be starving him to death and holding nutrition from him. History/ Investigations: His medications were ones that he has been taking for years and she doesn't know exact start dates for any and if she needs to she can get the dosage information from the pharmacy. Her brother has hid his pills before and he puts them in different bottles, it was a nightmare. He takes a gout medicine and she doesn't know the name of it. Those were the main ones that he takes other than the cancer medicine she said earlier. And he also takes gabapentin for some of his neuropathic pain and he takes something at night and a few others she thinks. For medical conditions the only thing that she knows was that many years ago he had a blood clot but she can't really say what year it was. She does know that her brother wasn't on any blood thinners to he knowledge and not long ago he had an ultrasound of his legs to determine if he had a blood clot but she was not 100 % sure if he had that but she thinks he did. Her brother told her that years ago he had blood clots that were due to weight lifting causing varicose veins and later they collateralized and they found out that the other secondary vessels took over for pumping his blood so it wasn't a problem. Her concern was can someone from Pfizer talk to her about what's going on with her brother, she knows Pfizer doesn't have his records but how will Pfizer be able to determine if this was from the COVID vaccine. She guesses that she was curious about what may of caused the blood clots. She mentioned the COVID vaccine to one doctor and he didn't seem like she respected her knowledge. She asked was there anything that can be done to help her brother if it was a blood clot. She was upset that the hospital and her wanting her brother to see a neurologist and beginning with a claim that he didn't have a stroke and then a claim that he did. She thinks that they were not doing enough for her brother and they were just saying oh well, it was all due to a fast heart rate which can happen as a result of the COVID vaccine. She was going to be honest, she was exhausted and she can't keep talking for a long time. She asked if she can call medical information back later when she was more refreshed. Consumer further stated that her brother had complaints of feeling ill, feverish and having no appetite. Caller stated that the next Thursday she found her brother unconscious, heart rate was elevated 120 to140 beats per minute and that her brother had a stroke. The outcome was recovered on 21Apr2021 for the events Malaise, Nauseated, Fatigue, Headache and Appetite absent; recovering for the event Vomiting; and unknown for the rest of the events. Information on lot/batch number has been requested.

gradually being short of breath/ huffing and puffing; This is a spontaneous report from a non-contactable consumer (patient's wife). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. About 8 days after the first dose in Jan2021, the patient started noticing gradually being short of breath. He would walk for 50 yards and he would be huffing and puffing which is unusual because he can walk a lot. It gradually got worse. Outcome of the event was not recovered. Patient received his second dose on 10Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

5/29/2021 Breathing Problem DIB, pulse ox 68% on RA Source of Information: Patient and Available medical record History of Present Illness: This is a 72y.o. male with extensive pmh as mentioned below Hypertension D.m. Copd on home o2 chf Cad Sleep apnea ckd and multiple other presented to ed with cc of sudden onset of sob and chills which started night before the presentation and associated with body aches.paitent was requiring bi pap on arival and was hypoxic Patient receive both doses of covid vaccine. Work up in er shows elevated d- dimer aqnd cta was not done because of his elevated kidney functions. Patient was tested positive for covid and id and pulmonary were consulted. troponins were elevated and cardiology also was consulted. Recommendations form the consultants were noted

Admit 5/22. Vaccine 3/1, 3/26. Admit for chest pressure, SOB, COVID PNA. CT showed mild opacities.Tx w/ antibiotics, zinc, singulair, Vit C. Used CPAP and BIPAP. DC home w/home health. Patient was admitted with COVID-19 pneumonia without respiratory failure. He was treated with supplemental medications including vitamin-C, zinc, singular. He did not required steroids. CT scan of the chest showed mild viral pneumonia patches. He was ruled out bacterial pneumonia and his antibiotics were discontinued at the time of discharge. His culture remained all negative till the time of discharge. He was feeling markedly better. His chest pressure was presumed from COVID-19 pneumonia and he was ruled out of acute coronary syndrome. Overall patient was feeling much better and he was discharged home with home health.

The patient made two visits to primary Dr. with swollen feet and ankles. Visits were a few weeks apart. Dr had Lab done the second visit and didn't see anything The next month Right foot was continuing to be swollen and had pain on bottom of foot.

headache; really started aching but he couldn't breathe; really started aching but he couldn't breathe; Chills; allergic reaction after getting the 2nd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route on 23Mar2021 at 12:30, last night or 1:00 (age at vaccination: 72-year-old) as a single dose for covid-19 immunization. Medical history included asthma, allergic to iodine and had covid in Feb2019. The patient concomitant medications were not reported. Past drug history included inhaler (antihistaminic) for 3 times a day for 4 days, when he had Covid in 2019. He said it seems like it was on the cuff of being a threat to his life. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route on 02Mar2021 as a single dose for covid-19 immunization. On 23Mar2021, patient experienced an allergic reaction after getting the 2nd dose of the vaccine. He mentioned that he experienced extreme difficulty breathing and he had chills, headache and really started aching but he couldn't breathe. He was wondering if he was going to die but he does not panic when he can't breathe because he has asthma but last night he was concerned. He had to take slow deep breaths through nose to survive it, but it wasn't working, and he wasn't getting enough air, but he fell asleep, and he got through it. He said the pharmacist said that people that who have had Covid have a harder reaction to the shot. He was struggling last night, and it was hard to breathe. He mentioned that his daughter, who is 47, and her family all got Covid infection, and she is having trouble breathing still, she can't even finish a sentence. He was wondering if this was something that ran in the family. He stated he is supposed to keep Benadryl with him, but it knocks him out and he was afraid if he went to sleep, he wouldn't wake up. He asked if this reaction was normal or if it was an allergic reaction. Therapeutic treatment taken as a result of the events included two antihistamines (ChlorTab 4 mg each), two Advil, and 2 shots of his albuterol inhaler and started coming around. The clinical outcome of aches and headache were not as bad and breathing is okay now, outcome of chills and allergic reaction was unknown. Follow-up (24Mar2021): New information received from a contactable consumer included: dates of 1st and 2nd dose of vaccination added, events added, therapeutic medications updated and medical history updated. No follow-up attempts are possible; Information about lot/batch number cannot been obtained.

Admitted 5/25. Presented to ER with c/o fever , SOB, cough, chilld, N/V/D. COVID+. Dx with COVID Pna; treated with remdesivir, decadron, plasma. Discharged 6/1 home.

Chest pain (not the angina I experienced prior to CABG 7.5 years ago) Shortness of breath, particularly when bending over Feelings of having a fast-beating, fluttering, or pounding heart

Shortness of breath , chest pain , afib placed on blood thinner administered oxygen . Admitted to intensive care. Blood clots in both legs and both lungs

Asymptomatic screening for admission for AKI ED to Hosp-Admission Current 6/22/2021 - present (3 days) MD Last attending ? Treatment team AKI (acute kidney injury) (CMS/HCC) Principal problem Review of Systems Constitutional: Negative for chills and fever. General weakness. HENT: Negative for ear pain and sore throat. Eyes: Negative for pain and visual disturbance. Respiratory: Positive for shortness of breath. Negative for cough. Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations. Gastrointestinal: Negative for abdominal pain and vomiting. Genitourinary: Negative for dysuria and hematuria. Musculoskeletal: Negative for arthralgias and back pain. Skin: Negative for color change and rash. Neurological: Negative for seizures and syncope. All other systems reviewed and are negative.

He felt heart palpitations; gasping for breath, trying to catch his breath, and had trouble breathing; Light headed and dizzy; He threw up his whole dinner/ upchucking; Dehydrated; His blood pressure dropped to 80/40; Very weak; This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself that a 72-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6208, Expiry Date: unspecified), via an unspecified route of administration on 12Mar2021 15:30 (at the age of 72-years-old) at right arm as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and post vaccination the patient was not diagnosed with COVID-19. The patient's medical history was left kidney removed on 21Dec2020. He had a major operation(detail not provided). He is sure they loaded him up with all kind of medication. He had no known allergies and not allergic to medications, food, or other products. Other medications the patient received within 2 weeks of vaccination was Metoprolol started about 4 years ago, for blood pressure and heart rate and folic acid started taking it about 3 years ago; both were continued. On 12Mar2021, 19:00, the patient came home an hour or so later, had dinner at 5:00 pm with 2 glasses of wine. At 7:00 pm he sat in his recliner and initially said he felt heart palpitations (it was clarified with the patient and he denied he had heart palpitations) and later clarified he was gasping for breath, trying to catch his breath, and had trouble breathing. He had lightheaded and dizzy, very weak, and he threw up his whole dinner/ upchucking (ended after probably about 1 hour, by then he was done). As a result of that, he became dehydrated. The paramedics told him that. His wife called the paramedics, he was taken to the Emergency Department by ambulance. He couldn't get out of the chair they had to lift him and carry him out to the ambulance. He received an Epinephrine shot and 2 bags of fluids, and his blood pressure dropped to 80/40 (4 hours after the shot was taken to the emergency room). The patient confirmed that he was not actually admitted. It was a surveillance. The low blood pressure ended an hour or so after. His shortness of breath ended 2-3 hours after the Epinephrine injection. More like, a little more than 2 hours. When asked outcome of dizziness caller reported he was very weak, that was hours later can remember still feeling that way lying in the emergency room, may have been about 4 hours. The patient was in emergency room for one day observation for all adverse events. He was discharged home on 13Mar2021. Lab tests (chest x-ray, blood work) were not required. Epi Pen was received as treatment for the adverse event. It was verified that he got and recovered completely from those events on 12Mar2021. Follow-up (22Mar2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself. No follow-up attempts are needed. No further information is expected.

Pt.'s wife states pt. experiencing shortness of breath, fatigued, arm soreness, headache, nauseous, left neck pain moving to the right side, 2nd shot muscle pain in the back continuing to move down towards buttock. Suffered a stroke 05/10/2021, shortly recovered with semi-weakness still on/off. PT recommended and home-health required. Stroke (right-side of brain) Did not preform an ultra-sound to locate potential of future clots.

Shortness of breath , I was treated at the emergency with Atrial Fibrllation, SYSTOLIC HEART FAILURE, CHRONIC

Really worn down/wound up sleeping about 10 hours; chills; shaking; hyperventilating(gasping); chest pounding; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on unspecified date in Jun2021 (at the age of 72 years old), as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation and no adverse event was reported. The patient was 72 years old while taking BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose. Patient reported that after receiving second dose, the next day (in Jun2021) he was really worn down, wound up sleeping about 10 hours that night (which was not normal) but then felt better the next day. He stated that after he received his 2nd COVID-19 shot, he had chills, shaking, was hyperventilating (gasping) and had chest pounding. Outcome of the event sleepy was recovered on an unknown date in Jun 2021 and for other events it was unknown. Information on lot/batch number has been requested.

Breakthrough COVID-19 case and hospitalized. Patient experiencing fever, cough, chills, fatigue, rigors and shortness of breath since 7/12/21. Patient has congestive heart failure and has a pacemaker/defibrillator. Reports having shortness of breath at baseline at times.

I had chest pain and went to the ER. I was diagnosed with pericarditis and pericardial effusion. A few weeks later, I had heart arrythmias and pleural effusions.

Resident appeared to be jaundice with yellow skin and eyes. Resident also complained of not feeling well. Urine was dark yellow. Resident short of breath. Resident was admitted to hospital and diagnosed with post-covid pneumonia.

Reaction was shortness of breath, headache, overall weakness, non-stop coughing with constant mucous, sore chest for a couple of days due to cough, injection site on L arm just a little sore Treated reaction with home remedies - Essential Oil Breathe cough drops, diffuser and drops in CPAP machine for several nights after the reaction. Breathe ointment in stick form on his chest Physician was contacted on 1/17/2021 and doctor advised him to go to the clinic. He did not go to the clinic due to improvement and the fact that he had an upcoming doctor appointment on 1/27/21

The patient developed shortness of breath 5 hours after receiving the Covid 19 vaccine on 1/29/21.He had "heavy wheezing " and finally went to the local ER the next day around 6 pm. He was treated with prednisone oral and felt immediate relief.

2/4/2021 12:00 Noon- After receiving his first COVID vaccine, he began to experience throat swelling with tremors. The vaccination station administered Epi and brought him to the ED for further evaluation. At 12:27, patient was feeling improved and left ED. The ED physician offered steroids and he did not want anything prescribed. He was instructed to return if symptoms worsen or do not improve. After he left the ED, he called his PCP and stated that the ED was no help and they had tried the CDC and Health department with no luck. Patient informed his PCP that he is experiencing elevated BP, dry sore throat, and dizziness to the point of passing out. The conversation between the patient and provider are ongoing at this time.

Progress Notes Nurse Practitioner Cosign Needed Expand All Collapse All Patient: DOB: 10/1/1947 Date: 2/4/2021 Subjective Patient is a 73 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience SOB and throat tightness and abdominal pain. He denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt is a diabetic ate last at 8 am. Blood sugar 234 at 15:12. ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath and abdominal pain Previous Reactions: None Objective Vitals There were no vitals filed for this visit. Blood Sugar 234 collected at 1512 Physical Exam Constitutional: Appearance: Normal appearance. He is well-developed. HENT: Head: Normocephalic and atraumatic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion and neck supple. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Bowel sounds are normal. Palpations: Abdomen is soft. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: Mental Status: He is alert and oriented to person, place, and time. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Pt left at 15:28

Reported nausea/dizziness/SOB. Called over EMT for eval. BP and HR normal. Pt reports feeling better. EKG normal.

73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department

For the two days prior to presentation the patient had been complaining of chest pain, his breathing seemed to be labored Monday. He and the family thought the pain was due to shingles as he carried this diagnosis from a month ago. Patient had also received the COVID vaccine 2 days prior to presentation and assumed he was feeling unwell due to the vaccine. Family wanted to take him to the hospital yesterday and earlier today but he refused. She left him in his home earlier this afternoon prior to presentation and returned to check on him finding him unresponsive and apneic at which time EMS was activated. #cardiac arrest -- suspect primary cardiac given collateral from family at home, consider hypoxemia which was corrected with advanced airway and 100% FiO2, patient clinically euvolemic and with soft brown stool in diaper not suggestive of GI hemorrhage, attempt to address acidosis with CPR and bicarbonate, not hypoglycemia, on bedside ultrasound FAST neg and no pericardial effusion suggestive of tamponade and +lung sliding bil not spontaneous pneumothorax Assessment/Diagnosis: -cardiac arrest, cause unspecified

Pt received his first dose of the Pfizer COVID-19 vaccine on 2/2/20201. Pt presented to a local ED on 2/10/2021 with symptoms of dyspnea and respiratory distress and was transferred/admitted to our hospital. He tested positive per PCR testing for SARS-CoV-2 on 2/10/2021. He is still currently admitted to our hospital receiving care. It was noted in his H&P that he had a COVID exposure approximately 2 weeks prior to presenting to the ED (unknown if he was alerted to this before getting his vaccine). He is currently recieveing remdesivir and dexamethazone to treat his COVID.

1st dose COVID vaccine 1/30/21; developed shortness of breath 2/7/21; worsening symptoms SOA, falls, chest pain; seen in ED on 2/12/21; Admitted to Hospital for severe sepsis, acute respirator failure.

Resident observed shirtless sitting in wheelchair with 02 @ 2L/M via NC in progress, using substernal accessory muscles, flared nostrils, pursed lip breathing. Alert verbally responsive, unable to speak more than 2-3 words at a time. Reports " I cant breathe". R 30 P 100 02 Sat 89%. Rebreather mask administered, and EMS initiated and transferred patient to emergency room, where he was admitted for respiratory failure.

My dad received the Pfizer vaccination on 2/5/21. He was admitted into the hospital the next day for C-Diff bacterial infection. He had been on dialysis treatments for kidney failure treatment since 2017 and had recently been diagnosed with stage 3 colon cancer in June 2020. He had completed his final treatment of chemotherapy on 2/4/21 and several weeks prior had been determined cancer free. On Tuesday 2/9/21 he was released from the hospital and went home. Early Thursday morning 2/11/21 @ approximately 1:30 am CST his eyes rolled back in head and he stopped breathing and was non responsive. My mother called 911 and attempted CPR. Paramedics arrived and were able to successfully get a pulse then transferred him to the hospital. He was put on a ventilator @ the hospital and then transferred to a different hospital a few hours later. He lost pulse/heartbeat several times @ the 2nd hospital he was transferred to. We were not allowed to travel with him or see him b/c of all of the COVID restrictions. We were communicating with the ICU doctor by phone who ultimately communicated to us that there was nothing further that could be done to save his life. He subsequently passed away @ approximately 8:55 am CST on 2/11/21.

Patient complained of shortness of breath (history of COPD) - resolved with albuterol. BP 177/100 (pulse 72); after observation, went down to 140/90 (pulse 72).

Patient presented to ED with progressively worsening angioedema presumably due to either h/o heraditory angioedema, lymphoma, or in combination with recent Covid vaccine. Patient had swelling to the lips, throat, and neck. Patient had similar symptoms in the past that resolved spontaneously within a day or received ecallantide on a different occasion in 2015. Suspected angioneurotic edema per hematology and was treated with epi, Benadryl, Pepcid, Solu-medrol, and Kalbitor for HAE. No edema visualized, clear voice, and no issues with swallowing on the next day.

Tiredness, chills, joint pain, injection site redness, feeling unwell; difficulty breathing at times, dizziness and weakness. Still on going event. Went to doctor. See below

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe

still wasn't feeling too well; Slightly elevated temperature of 98.9; Breathing really fast; Headache; Shivering; This is a spontaneous report from a contactable nurse. A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on 21Feb2021 (about 9:20AM-9:30AM) at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient was vaccinated with the first dose of BNT162B2 on an unspecified date at 73-year-old for COVID-19 immunization. The patient had his second COVID-19 Vaccine yesterday, 21Feb2021 and had a significant reaction. Last night (21Feb2021), about 12 hours later, he started getting a headache, he was breathing really fast, and shivering. He tried to calm himself down and went to bed. This morning (22Feb2021) he got up around 7AM and still wasn't feeling too well. His temperature was slightly elevated at 98.9 on 22Feb2021. His normal temperature is 97.1. He knows his own body and was pretty convinced his reaction was from a slightly elevated temperature and everything that comes with that. He went back to bed this morning and slept until 11:30AM. He got up and felt good. He took his temperature a few minutes ago and it was back to 97.1. The outcome of the events was recovered.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), to reported events cannot totally be excluded.

Patient received second Covid vaccine 3 days prior to admisssion. He presented to the emergency department for worsening shortness of breath, cough, decreased appetite, and generalized weakness for about 2 to 3 days associated with diffuse abdominal colicky pain. He reports of a progressively worsening weakness/fatigue over the last 3 days associated with poor oral intake with nausea but no vomiting.

Adverse reaction was not to the immediate vaccine. The adverse reaction being reported is that patient has tested positive for COVID-19 on 3/10/21, almost 1 month after second vaccination. Pt has been hospitalized since 2/20/21 for 1. Suspected acute toxoplasmosis 2. Severe sepsis with encephalopathy, transaminitis and acute respiratory failure d/t #1. He had tested negative for COVID per NP PCR tests twice prior to testing positive for discharge to SNF with associated chest pains. This has prolonged his existing hospitalization